Job Description
Our Quality Assurance group ensures our products are manufactured, processed, tested, packaged, stored and distributed in alignment with our incredibly high standards of quality and meet all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Quality Line Oversight Program at West Point focuses on early career talent development providing hands-on experience in pharmaceutical quality assurance supporting our Company’s largest and most complex vaccine manufacturing plant site. This program also supports opportunities to further learn, upskill, and network within different parts of the business outside of the primary responsibilities for career development purposes.
The targeted start date for this position will be in the spring, summer, and/or fall of 2024.
The position will be a direct manufacturing support role primarily on the shop floor within our Quality Line Oversight team. This team rotates through the vaccine filling and packaging departments at the West Point site providing quality and compliance oversight to our 24/7 manufacturing operations.
Primary responsibilities involve:
Quality checks of finished product including visual inspection of vials, syringes and packages
Verification of appropriate line clearance between batches to prevent product mix-ups
GMP document / batch record review
Additional responsibilities include:
Internal/external audit support
Continuous improvement projects by partnering with Operations, Technology, and/or other Quality groups in areas such as safety, quality, and efficiency
The shift structure for the position includes 12-hour day and night shifts which rotate approximately every two months. The position does require weekend coverage.
This is an entry level position, and 0-2 years of experience in pharmaceutical industry through internships, co-operative education or other roles is preferred.
GENERAL PROFILE:
Contributes to the performance and results of a vaccine manufacturing department.
Provides regulatory, quality and compliance guidance.
BUSINESS EXPERTISE:
FUNCTIONAL EXPERTISE:
Works as a team member on shop floor core tasks, quality systems activities and/or process improvement projects.
Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
Assures consistent application of standardized work, process tools, and procedures.
Assists with regulatory inspections in either documentation area, request management area or inspection room.
Provides quality guidance to technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
Effectively collaborates with peers on site and above site as required.
Education Minimum Requirement:
Required Experience and Skills:
Willing to work alternate shifts and weekends
Ability to focus on and obtain results
Good verbal and written communication skills
Ability to effectively collaborate within and across an integrated manufacturing team
Ability to enact conflict resolution
Ability to effectively respond to change
Excellent analytical and organizational skills
High personal integrity, credibility and energy
Flexibility to perform related tasks to support the business
Computer literacy in MS Office, Word, Outlook, Excel
Preferred Experience and Skills:
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
MMD2024
FTP2024
ETJobs
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Specified
Shift:
1st - Day, 2nd - Evening, 3rd - Night
Valid Driving License:
No
Hazardous Material(s):
NA
