Job Description
Job Description - Associate Specialist, Quality Line Oversight
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 is an entry level 2 year program with 8 month rotations focused on providing hands-on experience in pharmaceutical quality assurance supporting our Company’s largest and most complex vaccine manufacturing plant site. This entry level program provides individuals with a range of experiences across several core quality functions fostering a foundational introduction to the vaccine manufacturing business. This multi-faceted program supports opportunities to learn, upskill, and gain meaningful experience across different parts of vaccine manufacturing, facilitating future career development and job opportunities. The successful candidate will be part of the Quality Line Oversight Program as a Quality Associate Specialist located at the West Point, PA site. In addition to hands-on shopfloor experience, the employees will be provided with an exciting opportunity to participate in a quality rotational program. This program is designed such that employees will be assigned with appropriate mentors within various key areas of the Quality organization as part of the rotation. The employees will be provided training and shadowing opportunities and will gain exposure to tasks within key areas of quality, providing the employee with a broad view of the work at West Point At the completion of the QLO program including the rotations, successful individuals will be assigned to a Quality or Operations Specialist role to further develop the individual’s knowledge of the vaccine manufacturing business as well as help position them for future career growth.
The targeted start date for this position will be in June 2025 and December 2025.
The QLO Associate Specialist position is 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:
- Rotational support of Quality Assurance, Quality Operations, and Environmental Monitoring providing a foundational understanding of vaccine Quality oversight and production.
- Continuous improvement projects by participating in problem solving and 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 9 weeks. The position does require weekend coverage. Both the initial QLO assignment and future opportunities can include off-shift/off-schedule support within a vaccine manufacturing operations area.
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:
- Applies technical, collaboration and interpersonal skills to align activities with department objectives.
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:
- Bachelor’s Degree in Engineering or Sciences
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:
- 0-2 years working experience in cGMP pharmaceutical environment
- Experience using Lean/Six Sigma tools
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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, Monday - 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”.
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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:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day, 2nd - Evening, 3rd - Night
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
06/30/2025
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