Total 14 Senior Executive level Quality Assurance / Control job vacancies in US-IA-Iowa (Remote Employees)

LOCATIONS: Gurgaon/ Noida/ Pune/ Jaipur/ Bangalore/ Hyderabad

REQUIREMENTS:

• Experience: 8+yrs
• Must have: Functional Consultant, SAP Digital Manufacturing Cloud (Strong), SAP Manufacturing Execution System (MES) (Expert), SAP PP (Strong)
• Extensive experience in SAP DM, MES, MII, PCo, and DCS with strong understanding of processes and configuration, hands-on experience with MES systems and their integration with ERP, and knowledge of DCS and Plant Connectivity (PCo) along with expertise in end-to-end testing for upgrades and SAP Cloud releases is essential.
• Responsibilities include analysing client needs and functional requirements, define technologies and frameworks for solutions, and implement design methodologies and tools and coordinate application development requirements and schedules, lead/support UAT and production rollouts, and create and validate WBS and effort estimates.
• The consultant will address issues promptly, provide constructive feedback, set clear team expectations, troubleshoot and resolve complex bugs, propose and justify solutions during code/design reviews, and conduct POCs to ensure design/technologies meet requirements.
• Good understanding of design patterns, Concurrent design and multithreading.
• Strong troubleshooting skills in different disparate technologies and environments.
• Enthusiastic about different areas of work and exploring new technologies.
• Clarity of thought and strong communication skills to effectively pitch solutions.
• Ability to explore and grasp new technologies.
• Mentoring your team members in projects and helping them keep up with new technologies.
• Empowering the team members to be solution providers and enable a flat environment where everyone’s point of view is considered and feedback is encouraged.

RESPONSIBILITIES:

• Writing and reviewing great quality code
• Understanding the client’s business use cases and technical requirements and be able to convert them in to technical design which elegantly meets the requirements
• Mapping decisions with requirements and be able to translate the same to developers
• Identifying different solutions and being able to narrow down the best option that meets the client’s requirements
• Defining guidelines and benchmarks for NFR considerations during project implementation
• Writing and reviewing design document explaining overall architecture, framework, and high-level design of the application for the developers
• Reviewing architecture and design on various aspects like extensibility, scalability, security, design patterns, user experience, NFRs, etc., and ensure that all relevant best practices are followed
• Developing and designing the overall solution for defined functional and non-functional requirements; and defining technologies, patterns, and frameworks to materialize it
• Understanding and relating technology integration scenarios and applying these learnings in projects
• Resolving issues that are raised during code/review, through exhaustive systematic analysis of the root cause, and being able to justify the decision taken
• Carrying out POCs to make sure that suggested design/technologies meet the requirements

It's fun to work in a company where people truly BELIEVE in what they're doing!

We're committed to bringing passion and customer focus to the business.

DUTIES/ RESPONSIBILITIES including but not limited to:

• Responsible for In Process Quality Controls, day to day quality performance in manufacturing (e.g. DPMO, FPTY, MRB) and     continuous improvement with systemic approaches
• Readily available to solve real-time manufacturing quality issues while residing mainly on the production floor
• Coordinates external audits, prepares the internal team, agenda and meetings 
• Supporting Site Quality Leader in registrar, customer and internal audits
• Executes the internal quality audit programs for their respective site
• Coordinate with Site Quality Leaders on decisions affecting QMS and maintenance of quality and environmental certifications and standards (ISO, IPC, etc.) for their site
• Manages Suppliers Quality Performance, monitoring and determining systems to improve top hitters and assists with resolving supplier performance issues
• Supports with training needs as required, providing guidance and coaching to QEs, and responsible for training and     development of local quality engineering support personnel
• Coordinates and conducts frequent cell level process layered audits with QE personnel and other site functional leaders
• Assists with regional and site quality initiative projects
• Assists to define achievable quality KPIs for their site
• Supports and assists other Quality Engineers in the Customer Focused Team for systemic issues and CAPA resolution
• Manages and collects systemic data for process improvement
• Sustains knowledge of quality and regulatory changes applicable to their manufacturing site
• Takes a systemic approach on initiatives that improve the quality system, using data and inputs from various processes and different accounts
• Keeps Site Quality Leader fully apprised of significant occurrences and trends that impact the quality of processes, quality systems or supplier quality operations

QUALIFICATIONS:

• A Degree in Engineering or related technical discipline, and/or a combination of education and experience is required
• Minimum of 7 years’ experience in a manufacturing environment as a quality engineer or equivalent
• Demonstrated working knowledge of ISO 9001 and 13485 standards is required
• Work experience in a cGMP FDA 21 CFR Part 820, AS9100, AS9102 and ISO 14001 environment is strongly desirable
• Working knowledge and comprehension of quality management systems, measuring techniques, tools and equipment
• Strong technical skills required including electronics and electro-mechanical principles
• Experience in a PCBA low volume high mix or PCBA NPI desired 
• Knowledge of Statistical Process Controls (SPC), implementation and reporting
• Ability to lead problem solving activities with site level teams executing effective corrective actions
• Familiarity with inspection practices and solder knowledge 
• Experience in the application of Lean and Six Sigma Methodologies – CSSGB or CSSBB desirable
• ASQ CMQ/OE, CQE or CQA certification highly desirable

SKILLS REQUIRED:

• Highly proficient in MS Office Word and PowerPoint with advanced knowledge in Excel
• Excellent communication and interpersonal skills adaptable to all levels of the organization
• Seasoned at providing coaching, feedback and assisting in conflict resolution
• Ability to manage multiple concurrent projects and to deliver results accurately and on time
• Strong organizational and problem-solving skills
• Entrepreneurial, creative and high-energy team player with the proven ability to balance competing priorities
• Must be detail oriented, organized, and have ability to inspire others towards a quality minded culture
• Must be capable of working independently to achieve project schedules and goals
• Driven by a high degree of integrity, with cultural and core value alignment to Creation
• Strong learning mindset 

WORKING ENVIRONMENT:

Physical Demands

• The incumbent must be able to safely maneuver around the facility

Mental Demands

• Emotionally capable of professionally handling high-pressure situations in a fast paced, highly demanding industry 
• Capable of excelling in quality investigation type situations where listening and collaborating are essential to determine next steps and solutions

Working Conditions

• Equal mix of office and production environment. Available for quality support to 2nd shift as needed.
• You will be required to wear safety clothing and gears when working in safety sensitive environments

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.

Canada: Title for the position will be in accordance with applicable national and local laws.

We empower the best people to help sustain our world. 100% employee-owned. Independence guaranteed.

Company:

Description:

The Senior Vegetation Management Inspector (SVMI)-TRAQ position is ideal for seasoned forestry professionals with an educational background in forestry, horticulture, arboriculture, environmental studies, conservation, or related disciplines and with experience in these fields and line of work.

Contingent at the approval of our contractors, our Senior Vegetation Management Inspector-TRAQ may support Vegetation Management Inspector (VMI). Performs inspections, audits, and monitors contractor performance. Plans, directs, and coordinates the activities of assigned tree clearance crews. Serves as a liaison between clients, tree crews and customers.

Note: This position is designated as a safety-sensitive role.

*Active TRAQ Certification required*

Duties & Responsibilities:

• The SVMI (TRAQ) shall resolve obstacles to allow for the completion of the work in a safe, cost effective, efficient, timely, and productive manner, such as managing time and expenses (T&E) in the field, to minimize rework and drive quality.
• The SVMI (TRAQ) may manage day-to-day activities to ensure personnel stay focused on the assigned job and verify appropriate scope is being achieved, applicable equipment is utilized, and proper documentation updated.
• The SVMI (TRAQ) may act as the VM contact for new business and re-construction work requested by the Energy Delivery organization.
• With PG&E representative approval, the SVMI (TRAQ) may approve scheduling and scope changes in the field.
• The SVMI (TRAQ) shall encourage public, contractor, and employee safety on site at all times by promoting positive leadership, positive safety culture, good catches, exhibiting an absolute commitment to safety for self and others, and by ensuring all applicable safety rules, regulations and standards are followed. Performs and documents Safety Observations and Good Catches.
• The SVMI (TRAQ) may audit work performed by VMIs to ensure compliance with applicable standards.
• The SVMI (TRAQ) may assist with the training and onboarding of VM Inspectors.
• The SVMI (TRAQ) may support PGE Work Verification team to ensure observations are being properly addressed in a timely
• As directed by a PG&E representative, the SVMI (TRAQ) shall maintain working relationship with all public agencies including but not limited to Caltrans, CalFire, USFS, and BLM.
• The SVMI (TRAQ) shall maintain working relationship with PG&E’s tree contractors to assist in escalated work such as customer complaints

Basic Responsibilities:

• The SVMI (TRAQ) shall patrol distribution or transmission circuits and prescribe work to be performed by PG&E’s tree contractor, ensuring that the clearances prescribed will maintain compliance for a minimum of one calendar year.
• The SVMI (TRAQ) shall determine when the next trim is required and whether a trim or removal is necessary, assessing all trees with the potential to strike PG&E facilities for failure likelihood and hazards.
• Patrolling, identifying, and prescribing required tree pruning and tree/brush removal Work needed to facilitate completion of electric compliance tags such as 540 tags to meet all regulatory requirements and/or to PG&E Vegetation Management standards and procedures.
• The SVMI (TRAQ) shall ensure that their work is performed in accordance with PG&E Vegetation Management Standards and Procedures, project specifications, applicable permits, and safety requirements, and in compliance with all governing federal, state, and local jurisdictional agencies.
• The SVMI (TRAQ) shall be required to utilize computers and be capable of running reports and updating data within PG&E’s VMDSRs.
• The SVMI (TRAQ) shall be capable and comfortable working with software applications such as Excel, Word, and PowerPoint.
• The SVMI (TRAQ) may perform Quality Check audits on assigned VMIs, focusing on field compliance and data integrity.
• The SVMI (TRAQ) may be required to assist in outage investigations.
• The SVMI (TRAQ) may be asked to assist in the local Divisional Operational Emergency Center (OEC) in the role of Vegetation Resource Coordinator, as required.
• The SVMI (TRAQ) may be required to assist in fire and incident investigation.
• The SVMI (TRAQ) may be asked to assist in customer claims investigations.
• As requested by the PG&E Representative, the SVMI (TRAQ) shall perform all necessary duties for emergency response in accordance with all safety requirements, laws and regulations, and applicable labor agreements.
• The SVMI (TRAQ) must assure all sections of line are patrolled according to the annual plan and VM patrol standards and processes, and that these patrols were correctly documented under PG&E’s mapping procedure.
• The SVMI (TRAQ) must identify and notify the PG&E representative of newly identified Idle and Private Lines.
• The SVMI (TRAQ) shall perform other Work as directed by the PG&E representative or PG&E standards and procedures.

Equipment, Environmental and Safety Requirements:

• Driving cars, trucks, forklifts, and other equipment
• Walking on uneven ground
• Exposure to excessive noise
• Exposure to extremes in temperature, humidity, or wetness
• Operation of foot controls or repetitive foot movement
• Exposure to dust, gas, fumes, chemicals
• Prolong periods of time sitting (driving/meetings/trainings)
• Various forestry-related equipment, including but not limited to clinometer, range finder, logger’s tape, DBH tape and various safety-related equipment such as hard hat, safety vest, safety glasses, etc.

Qualifications:

• Must meet the general requirement below:
• High School diploma or GED, AND
• Required to maintain a Class C driver’s license AND must meet one of the experience levels below.
• Active TRAQ Certification required

Candidates must be located within a 50 mile radius of Placerville, CA. For candidates that do not live within this radius and are unable to relocate, hotel costs will be paid for by ACRT Pacific.

Experience requirements (must meet one):

• Five (5) years of experience as a tree crew climber/tree crew foreman with at least two (2) years of line clearance certification OR
• Five (5) years of experience as a Vegetation Management Inspector and Certified Arborist OR
• Five (5) years of experience as a Registered Professional Forester OR
• Five (5) years of experience as a Utility Inspector or higher classification with at least one (1) year of vegetation management experience OR
• Four (4) years of Military Service with honorable discharge and at least one (1) year additional year of vegetation management inspection experience AND Approval by PG&E Representative

​

Required Skills:

• Ability to identify local trees and knowledge of growth rates
• High level of communication and organization skills required
• High level of Customer Service skills required
• Experience working with data collection devices and GIS software desired
• Proficient in the use of Microsoft Office Self-motivated, organized, production oriented
• Strong verbal and written communication skills
• Ability to work in varied terrain and inclement weather with flexible schedules (available nights and weekends as needed)
• Ability to learn and use company- or job-specific software systems.
• Ability to work in rugged terrain and inclement weather.
• Ability to read and follow maps.
• Accountability: accepts personal responsibility for quality and timeliness of work.
• Accuracy and work quality: performs work completely, correctly, and in a professional manner.
• Adaptability and flexibility: meets the changing conditions and situations in work responsibilities.
• Communications: possesses strong verbal and written communication skills and is able to present ideas in formal and informal situations.
• Creativity: possesses ability to develop and present new ideas and better ways of doing things.
• Dependability: is reliable and has the ability to do required jobs.
• Drive and achievement orientation: sets challenging goals for self and willingly puts in extra time and effort in crisis situations.
• Independence: possesses the ability to work independently.
• Interpersonal skills: builds constructive and effective relationships.
• Job knowledge: possesses sufficient skill and knowledge to perform all aspects of the job.
• Positive attitude: displays optimism about the work to be done and demonstrates a positive attitude towards customers, peers, and the company.
• Quantity of work: generates adequate amounts of work based on the job requirements.
• Work comparability: performs work that is comparable to other employees with the same length of service in the same position.​

Training:

• The SVMI must successfully complete all training to progress into SVMI or if hired directly into a SVMI position must successfully complete all training:
• OSHA 30-hour construction safety overview (Must be completed within six months of start date)
• Certified Tree Safety Professional (CTSP) or Certified Arborist (CA) from the International Society of Arborist with a Tree Risk Assessment Qualified (TRAQ) certificate. (Must be completed within six months of test eligibility)
• 911 Standby training (Must be completed within one month of start date)
• Working knowledge of QA/QC (Must be completed within one month of start date)
• Computer training (e.g., completion of forms, uploading of documents, accessing GIS) (Must completed within one month of start date)

Supervisor Responsibilities:

• Serves as liaison between client’s representative and Operations Manager to support colleagues and to monitor work group progress.

The tasks undertaken in this role are contingent upon the contractual agreement between ACRT Pacific and the Customer. Given the contractual nature of the role, it's important to note that it may not entail a permanent arrangement and could potentially conclude in response to an RFP or RFQ.

Salary Range Disclaimer

The base salary range represents the low and high end of the ACRT Pacific salary range for this position. Actual salaries will vary depending on factors including but not limited to customer contact terms, location,  experience, and performance. Other rewards may include Paid Time Off, 401(k) retirement savings plan with company match, ESOP contributions, medical, dental, and vision insurance, and other region-specific benefits as eligible. 

Salary Range Transparency

For applicants residing in California, the salary range for this role is $46.78 per hour.

Position Title: Senior Vegetation Management Inspector

Alternate Title: SVMI

Position Reports to: Operations Manager

Division: Operations

Department: Operations

Compensation: $46.78 an hour

FLSA: Non-Exempt

Bargaining Role: Yes

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Primary City/State:

Department Name:

Work Shift:

Job Category:

Great careers are built at Banner Health. There’s more to health care than doctors and nurses. We support all staff members as they find the path that’s right for them. Apply today, this could be the perfect opportunity for you.

Becker’s Healthcare recently honored Banner as one of 150 top places to work in health care for 2023, we are proud to offer our team members many career and lifestyle choices throughout our network of facilities. At Banner Health, we’re excited about what the future holds for health care. That’s why we’re changing the industry to make the experience the best it can be. If you’re ready to change lives, we want to hear from you.

The role is Monday - Friday 8 AM - 5PM, the location is remote and the team is open to out of state candidates but would like their team to be available to be onsite once per quarter. In this role you will be responsible for managing audits, mentoring staff, and managing reporting for all Banner plans and networks. If you have audit experience with knowledge in health plans and healthcare this would be an ideal role for you!

Your pay and benefits are important components of your journey at Banner Health. This opportunity includes the option to participate in a variety of health, financial, and security benefits.

POSITION SUMMARY
This position conducts scheduled audits defined in the annual audit plan, as well as, requested unplanned audits resulting from an internal request or a government investigation. Plans, coordinates and manages audits and third party investigations under the direction of compliance leadership. Conducts coding, billing and other business procedure audits and prepares and presents reports of findings at the direction of compliance leadership. Assists with the development of corrective actions and monitoring activities to mitigate risk and validate ongoing compliance with government regulatory requirements. Conducts internal investigations reported though the compliance/ethics line as applicable, assists the organization’s compliance officers as directed to research and investigate concerns or questions related to compliance or regulatory requirements. Provides support to compliance leadership during government investigations, including document indexing, medical record review, research regarding applicable laws and regulatory requirements, internal policies, procedures/operational processes and maintaining investigation file integrity.

CORE FUNCTIONS
1. Researches regulatory requirements relative to assigned audits and develops audit tools. Conducts audits utilizing defined audit standards, communicates the audit process through a pre-audit conference, identifies areas of potential risk, prepares audit reports, communicates results though an audit exit conference, assists in the development of corrective action plans, monitors effectiveness of corrective action plans, and provides training if indicated.

2. Identifies training opportunities based on audits, designs and presents such education to prevent repeated compliance risks at the direction of the compliance leadership team. Provides compliance/documentation education sessions to physicians and other staff.

3. Coordinates external investigation efforts in conjunction with the Banner Legal Department and Compliance leadership. Maintains investigation integrity by managing investigation files, reviewing applicable laws and regulations, Banner internal policies and relative operational processes.

4. Assists the organization's compliance leadership, as directed, to research and investigate complaints, concerns or questions relative to compliance issues. Investigates and follows up on reported issues as directed.

5. Maintains awareness of laws and regulations and conducts research as needed to identify applicable laws, regulations and practices to maintain compliance. Reviews related policies and procedures and literature. Communicates applicable compliance issues to the compliance officers and assists in the distribution of training of such changes.

6. Assumes additional responsibilities to assist and support the organization's compliance program often dealing with complex and unique situations and problems.

7. Performs job functions on a system-wide basis. Internal and external customers include, but are not limited to, executives and managers, compliance committees, physicians and clinical staff. Must maintain relevant professional licensure/certification.



MINIMUM QUALIFICATIONS

Requires knowledge typically gained with completion of a bachelor's degree in business, nursing, internal audit or related field.

Requires skills and abilities normally acquired with two to three years of payer, clinical or healthcare operations experience and/or three to five years of experience in medical coding or audit experience within a complex care or payer environment. Must be able to understand, apply and interpret complex rules and regulatory requirements in a variety of payer or provider settings and relevant healthcare-related government regulations, including Medicare and Medicaid.

Requires clinical or payer knowledge, critical and analytical thinking skills to conduct compliance audits and draft reports. Written and verbal communication skills required. Computer skills in word processing and spreadsheets required. Ability to organize workload, manage multiple projects, and maintain confidentiality of all work information.

PREFERRED QUALIFICATIONS

Relevant certification based on assigned area of focus. Experience in Payer or Healthcare operations, regulatory requirements, legal, revenue cycle, coding registered nurse (RN) or audit standards preferred as relevant to the position.

Additional related education and/or experience preferred.

EOE/Female/Minority/Disability/Veterans

Our organization supports a drug-free work environment.

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Job Summary:

This is a key role within the Global Quality function, where you will have the objective of maintaining high quality standards for the product manufacturing and compliance with all applicable regulatory requirements. The scope is focused on Quality Compliance processes and is assured via the execution of the Corporate Quality Compliance Programs.

Key Duties & Responsibilities:

Internal Audit Process:

• Conduct Internal Audit and Corporate Audits as assigned.
• Ensure robust investigation of Audit Observations and adequate CAPA action plans, ensure alignment in Audit Non Conformance Ratings and review/approve CAPA as required related to Internal Audit Non Conformances.

External Audit Process:

• Support External audit process execution, from readiness to execution, help team to resolve compliance issues and timely and robust manner.
• Conduct review of External Audit CAPA effectiveness by collecting and analysing data accordingly

Compliance and Education Program:

• Maintain deep knowledge and keep abreast of all current regulatory and statutory expectations.
• Develop and Deploy related Compliance trainings.

Internal Quality Agreement:

• Lead and execute the process to maintain Internal Quality Agreements in compliance.

Regulatory and statutory expectations:

• Execute Regulation/Standard Gap Assessments and implementation as required.
• Support Quality Improvements projects to compliance/enhance compliance.

Integration/Divestiture:

• Execute Gap Assessments and implementation as required in relation to Quality Compliance Assessments.

The Ideal Candidate should bring the following qualities to the role:

• Practical knowledge and experience in diverse functions of the medical industry/pharma
• ISO13485 Auditor Certification and experience in executing audits
• Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style
• Ability to build and nurture strong and positive relationships with other leaders to partner effectively
• Balanced technical understanding of products and processes combined with business and compliance acumen
• Excellent use of Microsoft Office applications, ability to generate report in Excel and other systems for data analysis

Principal Contacts:

Internal: Global quality management, Site Quality Leads, R&D, Regulatory Affairs, Clinical Affairs, Quality Engineering, Quality Associates and all other functions as required by the role

Travel Requirements:

Periodic travel required. Once per Quarter.

Education/Qualifications:

• Minimum of B.S., or equivalent, in a scientific/technical discipline is required.  
• Five to Ten (5-10) years in the medical device and/or pharmaceutical industry.
• Two to Four (2-4) years’ experience in a QA/QC role.
• Practical experience and global mastery in global quality standards and regulations governing medical products.
• Six Sigma Green Belt/Black Belt certification or equivalent (preferred)

Working Conditions:

• Remote working

Language Skills Required:

• Speaking:                          English

• Writing/Reading:              English

Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen too.  It can be challenging.   But, as the progress you make will help improve the lives of millions, it’ll be worth it.

This is stepping up to a challenge.

This is work that’ll move you.

#ForeverCaring #ForeverConvatec #WeAreConvatec

#LI-DB1

#LI-Remote

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Associate Quality Complaints - Lab

Live

What you will do

Let’s do this! Let’s change the world! The Senior Associate in Quality Assurance at Amgen plays a crucial role in maintaining high-quality standards across the manufacturing processes. They lead audits, address quality issues, develop training materials for QA procedures, and ensure compliance with both internal guidelines and external regulations.

Amgen is seeking a Sr. Associate Quality Complaints – Product Complaints Return Lab, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and carries out the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Sr. Associate evaluates complaint related return unit samples. Maintains the product complaint laboratory in compliance with Good Laboratory Practices (GLP). Performs work in a manner consistent with GLPs. Executes day to day operations in the product complaint laboratory and ensures the daily workload is completed efficiently and with high quality (e.g. PMs, calibrations, and general servicing).

Key Responsibilities:

• Applies analytical skills to evaluate product complaint return samples using multiple sources of information

• Manages work in accordance with Good Laboratory Practices (GLPs)

• Interprets SOP requirements

• Identifies product quality and safety risk with product complaint return samples

• Provides technical advice on complaint investigations

• Provides subject matter experts assessments (Return Unit Inspections)

• Partners with FPT on return sample evaluations, establishing inspection criteria and inspection method.

• Performs return inspection for complaints

• Supports product security inspections as needed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

Master’s degree OR

Bachelor’s degree and 6 months of Quality experience OR

Associate’s degree and 2 years of Quality experience OR

High school diploma / GED and 4 years of Quality experience

Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelor’s Degree in a Science Field

• Ability to successfully manage workload to timelines

• Familiarity with basic project management tools

• Demonstrated ability to consistently deliver on-time, and high-quality results

• Ability to operate in a matrixed or team environment

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Associate Quality Complaints - Lab

Live

What you will do

Let’s do this! Let’s change the world! The Senior Associate in Quality Assurance at Amgen plays a crucial role in maintaining high-quality standards across the manufacturing processes. They lead audits, address quality issues, develop training materials for QA procedures, and ensure compliance with both internal guidelines and external regulations.

Amgen is seeking a Sr. Associate Quality Complaints – Product Complaints Return Lab, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and carries out the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Sr. Associate evaluates complaint related return unit samples. Maintains the product complaint laboratory in compliance with Good Laboratory Practices (GLP). Performs work in a manner consistent with GLPs. Executes day to day operations in the product complaint laboratory and ensures the daily workload is completed efficiently and with high quality (e.g. PMs, calibrations, and general servicing).

Key Responsibilities:

• Applies analytical skills to evaluate product complaint return samples using multiple sources of information

• Manages work in accordance with Good Laboratory Practices (GLPs)

• Interprets SOP requirements

• Identifies product quality and safety risk with product complaint return samples

• Provides technical advice on complaint investigations

• Provides subject matter experts assessments (Return Unit Inspections)

• Partners with FPT on return sample evaluations, establishing inspection criteria and inspection method.

• Performs return inspection for complaints

• Supports product security inspections as needed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

Master’s degree OR

Bachelor’s degree and 6 months of Quality experience OR

Associate’s degree and 2 years of Quality experience OR

High school diploma / GED and 4 years of Quality experience

Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelor’s Degree in a Science Field

• Ability to successfully manage workload to timelines

• Familiarity with basic project management tools

• Demonstrated ability to consistently deliver on-time, and high-quality results

• Ability to operate in a matrixed or team environment

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Position Overview:

We are seeking a seasoned Senior Manual QA Specialist with extensive experience in e-commerce, marketplace, and checkout process testing, along with proven expertise in mobile application testing. The ideal candidate will be deeply product-focused, with a keen eye for detail and a strong dedication to enhancing the end user experience. This role demands a deep understanding of RTM, regression testing, smoke testing, and other QA methodologies to ensure the highest quality standards for our products.

Key Responsibilities:

- Drive manual testing efforts for our marketplace platform, focusing on checkout processes and mobile application functionality.

- Design, develop, and execute test plans and test cases based on product requirements and technical specifications.

- Conduct thorough regression testing, smoke testing, and other types of testing as needed to ensure product quality.

- Utilize Requirements Traceability Matrix (RTM) to ensure comprehensive test coverage and traceability.

- Maintain a strong product focus, understanding the nuances of the e-commerce and marketplace ecosystem to identify and prioritize key areas for testing.

- Advocate for the end user, ensuring that user experience is at the forefront of our testing and development efforts.

- Work closely with development, product management, and design teams to identify and resolve defects early in the development cycle.

- Participate in agile ceremonies, providing QA insights and feedback to guide product iterations.

- Communicate effectively with technical and non-technical stakeholders to ensure alignment on quality standards and product goals.

- Stay abreast of the latest trends and technologies in manual testing, e-commerce, and mobile application development.

- Lead initiatives to improve QA processes, tools, and methodologies to enhance efficiency and effectiveness.

- Contribute to the development of a knowledge-sharing culture within the QA team and across the organization.

Required Skills & Qualifications:

- Experience with test management tools (JIRA, TestRail).

- Minimum of 5 years of experience in manual QA testing, with a focus on e-commerce, marketplaces, and checkout process testing.

- Proven experience in web application testing across the most popular OS/Browser combinations.

- Proven experience in mobile application testing across iOS and Android platforms.

- In-depth knowledge of QA methodologies, including RTM, regression testing, smoke testing, etc.

- Excellent problem-solving skills and attention to detail.

- Strong communication and collaboration skills, with the ability to work effectively in a team environment.

- Experience with Agile/Scrum development processes.

- A user-centric mindset and a commitment to creating the best user experience possible.

Preferred Skills:

- Certifications in QA methodologies (ISTQB, CSTE, etc.).

- Bachelor’s degree in Computer Science or Information Technology.

- Knowledge of automation testing tools and frameworks is a plus.

Groupon’s purpose is to build strong communities through thriving small businesses. To learn more about the world’s largest local ecommerce marketplace, click here. You can also find out more about us in the latest Groupon news as well as learning about our DEI approach. If all of this sounds like something that’s a great fit for you, then click apply and join us on a mission to become the ultimate destination for local experiences and services.

Beware of Recruitment Fraud: Groupon follows a merit-based recruitment process without charging job seekers any fees. We've noticed an increase in recruitment fraud, including fake job postings and fraudulent interviews and job offers aimed at stealing personal information or money. Be cautious of individuals falsely representing Groupon's Talent Acquisition team with fake job offers. If you encounter any suspicious job offers or interview calls demanding money, recognize these as scams. Groupon is not responsible for losses from such dealings. For legitimate job openings, always check our official careers website at grouponcareers.com.

Be visionary

Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research.​

We are looking for individuals who thrive on making an impact and want the excitement of being on a team that wins.

Job Description

 Job Summary:

• To represent Product Assurance as part of a new US-based sonar development team to deliver development and acceptance testing to software and hardware development. A major part of this role will be managing and maintain a test boat which will be based close to the development team.

Primary Duties & Responsibilities:

• Maintain readiness of a Teledyne-owned boat which will be located close to the development team
• Provide Captain and or crew support for the test boat
• Manage the boat to a defined budget
• Ensure seatrials are safely deployed at all times
• Ensure planned maintenance routines are carried out on the hull and fitted equipment
• Provide installation support & guidance for the fitting of Raymarine test products
• Liaise with local marinas and boat maintainers to achieve the above
• Requirements Capture – Input to requirements capture for assigned projects from a mariners and/or test perspective
• Product Qualification – Develop via analysis; create and conduct complex test plans that can be used by other team members to assess product performance & reliability
• Engineering QA – provide resource to control product build status/issue within product development.
• Benchmarking – conduct comparison/benchmark tests as a part of research & development for new and potential products
• Quality policy – ensure all activities meet the spirit of the policy
• Personal training – identify additional training appropriate for current or future work
• Carry out and contribute to risk assessments of issues from a mariner or user’s perspective

Job Qualifications:
 

Formal Education/Qualifications required:

• Formal qualification in a technical discipline preferred (electrical, electronic or software test) or
• On the job training to an equivalent standard or

The following would be essential:

• 3 Years + experience in a relevant technical role
• Boating experience as a regular crew or skipper
• Ability to install electronic/electrical equipment on a Sports Fishing Boat

The following would be desirable but not essential:

• Boat skipper qualifications
• Graduate in a relevant engineering discipline
• Experience in the US Sports Fishing market
• Relevant product testing experience
• Ability to use PC applications

Applicants must be either a U.S. citizen, U.S. national, legal permanent resident, asylee, refugee or must be eligible to apply for and obtain the appropriate export control license from the U.S. Departments of State or Commerce.

Teledyne and all of our employees are committed to conducting business with the highest ethical standards. We require all employees to comply with all applicable laws, regulations, rules and regulatory orders. Our reputation for honesty, integrity and high ethics is as important to us as our reputation for making innovative sensing solutions.

Teledyne is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other characteristic or non-merit based factor made unlawful by federal, state, or local laws. ​

Cardinal Health Overview:

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities.

We are a crucial link between the clinical and operational sides of care, working with more than 4,500 sourcing and manufacturing partners to deliver end-to-end solutions and data-driven insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care.

With 50 years of experience, approximately 44,000 employees and operations in more than 30 countries, Cardinal Health seizes the opportunity to address healthcare’s most complicated challenges — now, and in the future.

Department Overview:

Information Security and Risk Management (ISRM) at Cardinal Health enables Cardinal Health to securely deliver healthcare products and solutions that improve the lives of people every day by ensuring security and controls is embedded into Cardinal Health’s people, process and technology.

We currently have a career opening for a Sr. Engineer, Information Security and Risk, who will play an IT Privacy Compliance Program Run Lead role focused on driving IT Privacy Controls & Compliance for the organization.

Job Overview:

This role is a leader position within the team and requires having an in-depth understanding of local, national and international privacy and security regulations such as HIPAA (Health Insurance Portability and Accountability Act), GDPR (General Data Protection Regulation) and the CCPA (California Consumer Privacy Act) as well as relevant control frameworks to drive compliance to those regulatory requirements such as NIST, ISO, etc., while working with members of the Information Security and Risk Management team as well as privacy leaders in Legal, Ethics & Compliance and our various businesses throughout the Cardinal Health enterprise.  Senior Engineer will be responsible for managing operational activities (i.e., “Run”) of the IT Privacy Compliance Program, including confirming all assessments are completed, issue management and maintaining operational metrics. 

Daily Responsibilities:

• Leader over the “Run” activities of the IT Privacy Compliance Program as a Second Line of Defense (LOD) function.  Some of the key responsibilities include:
  • Create and manage calendar of IT Privacy Risk Assessments, while collaborating with appropriate risk functions to reduce redundancy of efforts, enhance reliance on Second LOD, and provide coverage across in-scope assets.
  • Lead management of all issues resulting from assessments to confirm appropriate stakeholder visibility and remediation recommendation, appropriate issue lead assignments, appropriate issue validation prior to closure, etc.
• Collaborate with IT Privacy Compliance Program Build Lead on driving overall success of the program.
• Build and implement metrics to report on effectiveness of the IT Privacy Compliance Program
• Partner with Legal counsel and Ethics & Compliance leaders to address regulatory or compliance requirements, issues, concerns or questions.
• Partner with IT and IT Security in the development of policies, procedures and practices in support of privacy and data protection compliance.
• Collaborate with IT and business leaders and team to provide guidance on doing privacy by design and remediating issues identified to enhance compliance to the regulatory requirements.
• Identify opportunities to automate various privacy and data protection compliance activities to reduce the overall cost of compliance.
• Mentor members of the team on how to effectively perform compliance assessments, complying to IT privacy regulation requirements, consultation on issue remediation recommendations and alternative solutions, etc.
• Effectively manage and implement change throughout the organization.

Qualifications:

• Bachelor’s Degree in related field or equivalent work experience
• 10+ years’ experience in related field
• Prior experience with key IT Privacy regulation compliance including HIPAA and GDPR compliance.
• Prior experience with control frameworks (e.g., NIST, HITRUST, COBIT, COSO, and ISO) to drive IT Privacy regulatory compliance.
• Prior experience working with Internal or External Audit functions are a plus.
• Experience with IT risk and controls identification and assessments including IT control design and effectiveness testing.
• Experience with GRC (Governance, Risk and Compliance)
• Experience in analyzing data and creating reports/dashboards/views to provide visibility into risk and control landscape.
• Ideal candidate will have excellent communication skills (both verbal and written) with leaders at all levels within the organization, an ability to work in a matrixed environment to drive results, and the ability to clearly define and execute repeatable processes.
• Ideal candidate will have an effective time management, active listening, meeting facilitation, and influencing skills.
• Ability to effectively navigate a variety of challenging environments, prioritize work and determine when to escalate to upper management.
• Security or risk certifications such as CISA (Certified Information Systems Auditor), CISSP (Certified Information Systems Security Professional) and/or CIPP (Certified Information Privacy Professional) certifications are a plus.

Anticipated salary range: $119,800 - $171,100

Bonus eligible: Yes

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 3/11/2024 *if interested in opportunity, please submit application as soon as possible.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

To read and review this privacy notice click here

What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Job Summary

The Senior Specialist, Quality Assurance is responsible for providing regulatory submissions in electronic format – drug establishment and drug listing requirements for Structured Product Labeling (SPL) format for repackaging and private label Rx and OTC. This individual will contribute to the oversight of Cardinal Health Pharmaceutical Private Label and of approved suppliers, manufacturers and repackagers.

Responsibilities

• Contribute to designing effective procedures, work instructions and/or processes to ensure compliance as well as efficiency.
• Processing Electronic Registrations and Drug Listings for repackaging.
• Clear understanding of guidelines for Structured Product Labeling (SPL) for both Rx and OTC.
• Data development and maintenance for repackage items in portfolio.
• SOP development and maintenance.
• Determine compliance of processes and regulations.
• Identify potential gaps to mitigate risk
• Implement improvements to internal processes.
• Works on complex projects.
• Acts as a mentor to those with less experience.
• Other activities as requested.

Qualifications

• BA, BS or equivalent experience in related field preferred
• 3-5 years of experience preferred.
• Comprehensive experience with Structured Product Labeling (SPL) preferred.
• Knowledge of cGMPs, 21 CFR 11, 210, 211, 820 and Structured Product Labeling (SPL) requirements preferred.
• Comprehensive knowledge of repacking operations preferred.
• Demonstrate critical thinking skills.
• Proficient with Microsoft Excel.
• Comprehensive knowledge and familiarity with products, processes, equipment, and facilities of pharmaceutical manufacturing and packaging.
• Comprehensive experience with drug/cosmetic listings preferred.
• Ability to work independently.
• Able to multitask and to reprioritize as required.
• Excellent interpersonal and critical thinking skills.
• Ability to travel 5% for in person meetings and/or regulatory inspections.

Location

• Fully remote
• Ability to travel up to 5% required for in person meetings and/or regulatory inspections.

What is expected of you and others at this level

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Anticipated salary range: $66,500-$95,000

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 03/29/2024 *if interested in opportunity, please submit application as soon as possible.

#LI-Remote

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

To read and review this privacy notice click here

• Manage Sodexo’s Information Security Management System (ISMS) and other information security compliance activities to maintain various certifications, including ISO27001, Cyber Essentials + and PCI DSS
• Conduct Information Security Third Party Assurance on Sodexo suppliers to mitigate Risk throughout the lifecycle of supplier relationships
• Support the wider Sodexo business with appropriate action plans and risk assessments for new contracts and other activities
• Improve Sodexo UK&I's information security practices by engaging with Sodexo Global colleagues, leveraging knowledge and technology from the wider business to improve regional practices

• Experience creating ISMS documentation to gain ISO27001 certification
• Practical experience of Cyber Essentials +, PCI DSS and UK government & MOD accreditations
• Prior work performing internal or external IT and security audits, as well as dealing with third party supplier audits
• Strong stakeholder management skills, with the ability to share important security updates with technical and non-technical colleagues
• The ability to achieve UK SC Security Clearance is a requirement of this role

• Flexible, dynamic and inclusive work environment
• Fantastic flexible benefits
• Access to ongoing training and development programs
• Countless opportunities to grow within the company