Associate Specialist, Quality Assurance

About the Role

Our 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. This program supports our Company’s largest and most complex vaccine manufacturing plant site, offering a range of experiences across core quality functions to build a foundational understanding of vaccine manufacturing.

The Quality Associate Specialist role is a direct manufacturing support position primarily on the shop floor within our Quality Line Oversight team. This team rotates through vaccine filling and packaging departments at the West Point, PA site, providing quality and compliance oversight for 24/7 manufacturing operations. The program includes mentorship, training, and shadowing opportunities across key quality areas, with a targeted start date of October/November 2026.

Upon completion of the program, successful individuals will transition into a Quality or Operations Specialist role to further develop their knowledge and career growth in vaccine manufacturing.

Responsibilities

• Perform quality checks of finished product, including visual inspection of vials, syringes, and packages.
• Verify appropriate line clearance between batches to prevent product mix-ups.
• Review GMP documents and batch records.
• Support rotational assignments in Quality Assurance, Quality Operations, and Environmental Monitoring to gain a foundational understanding of vaccine quality oversight and production.
• Participate in continuous improvement projects by collaborating with Operations, Technology, and other Quality groups to enhance safety, quality, and efficiency.
• Provide regulatory, quality, and compliance guidance to manufacturing teams.
• Assist with regulatory inspections, including documentation management and request handling.
• Contribute to technical and manufacturing documents for investigations, process design, engineering studies, change control, and validation.
• Ensure consistent application of standardized work, process tools, and procedures.
• Collaborate with peers both on-site and across the organization as required.

Requirements

• Bachelor’s Degree in Engineering or Sciences (minimum requirement).
• Willingness to work alternate shifts (12-hour day and night shifts rotating approximately every 9 weeks) and weekends.
• Ability to focus on and obtain results with strong analytical and organizational skills.
• Excellent verbal and written communication skills.
• Ability to collaborate effectively within and across integrated manufacturing teams.
• Strong conflict resolution and adaptability to change.
• High personal integrity, credibility, and energy.
• Flexibility to perform related tasks supporting business needs.
• 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.
• Familiarity with Lean/Six Sigma tools.

Skills

• Analytical problem solving and decision-making.
• Knowledge of cGMP compliance, aseptic filling, and quality assurance processes.
• Experience with manufacturing documentation, operational quality, and quality management standards.
• Ability to coordinate tasks, peer review, and adhere to procedures.
• Process improvement and results-oriented mindset.
• Leadership and competency management.

Pay

The salary range for this role is $71,900.00 – $113,200.00. An employee’s position within the range will be based on factors including education, qualifications, certifications, experience, skills, geographic location, and business needs. The successful candidate may also be eligible for annual bonus and long-term incentives, if applicable.

Benefits

We offer a comprehensive benefits package, including:

• Medical, dental, vision, and other insurance benefits for employees and their families.
• Retirement benefits, including a 401(k) plan.
• Paid holidays, vacation, compassionate leave, and sick days.

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Schedule

• 12-hour day and night shifts rotating approximately every 9 weeks.
• Weekend coverage is required.
• Both initial and future opportunities may include off-shift or off-schedule support within vaccine manufacturing operations.