Associate Specialist, Quality Assurance
Our Quality Assurance group ensures our products are manufactured, processed, tested, packaged, stored and distributed in alignment with our 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 delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
About the role
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 program offers a range of experiences across several core quality functions, fostering a foundational introduction to the vaccine manufacturing business. It 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 join the Quality Line Oversight Program as a Quality Associate Specialist located at the West Point, PA site. In addition to hands-on shop-floor experience, employees will participate in a quality rotational program with mentors across key areas of the Quality organization. Training, shadowing, and exposure to tasks within key quality areas will provide a broad view of operations at West Point.
Upon completion of the QLO program, successful individuals will be assigned to a Quality or Operations Specialist role to further develop their knowledge of the vaccine manufacturing business and position them for future career growth. The targeted start date for this position is October/November 2026.
Responsibilities
- 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 and batch record review.
- Rotational support of Quality Assurance, Quality Operations, and Environmental Monitoring to build foundational understanding of vaccine Quality oversight and production.
- Participation in continuous improvement projects, problem-solving, and collaboration with Operations, Technology, and other Quality groups in areas such as safety, quality, and efficiency.
- Examination of issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to understand and resolve root causes.
- Assurance of consistent application of standardized work, process tools, and procedures.
- Assistance with regulatory inspections in documentation, request management, or inspection room areas.
- Provision of quality guidance for technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control, and validation.
- Collaboration with peers on-site and across sites as required.
Requirements
- Bachelor’s Degree in Engineering or Sciences (minimum requirement).
- Willingness 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 Qualifications
- 0-2 years of experience in the pharmaceutical industry through internships, co-operative education, or other roles.
- Experience working in a cGMP pharmaceutical environment.
- Experience using Lean/Six Sigma tools.
Skills
- Analytical Problem Solving
- Aseptic Filling
- cGMP Compliance
- Cleaning Equipment
- Communication
- Competency Management
- Computer Literacy
- Decision Making
- Good Manufacturing Practices (GMP)
- Leadership
- Manufacturing
- Manufacturing Documentation
- Microsoft Word
- Operational Quality
- Peer Reviewing
- Procedure Adherence
- Process Improvements
- Quality Assurance Processes
- Quality Compliance
- Quality Management Standards
- Quality Standards
- Quality Support
- Results-Oriented
Schedule
- 12-hour day and night shifts, rotating approximately every 9 weeks.
- Weekend coverage required.
- Both the initial QLO assignment and future opportunities may include off-shift/off-schedule support within vaccine manufacturing operations.
Pay
The salary range for this role is $71,900.00 - $113,200.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Benefits
- Comprehensive medical, dental, and vision healthcare and other insurance benefits (for employee and family).
- Retirement benefits, including 401(k).
- Paid holidays, vacation, and compassionate and sick days.
More information about benefits is available at Merck Compensation and Benefits.