QA Specialist III (QOTF) - 12 Hour Days (2-2-3 shift)
Thermo Fisher Scientific
Summary
As a QA Specialist III – Quality on the Floor (QOTF), you'll play a critical role in maintaining quality and compliance across sterile pharmaceutical manufacturing operations. This is a highly visible, hands-on position where you'll work directly with manufacturing personnel to observe aseptic practices, assess production activities, identify potential compliance concerns, and provide practical guidance that supports safe and compliant manufacturing.
Job description
What will you do?
- Perform routine Quality Assurance oversight of sterile manufacturing, filling, packaging, and inspection activities to ensure compliance with cGMP requirements and site procedures.
- Conduct documented manufacturing-floor walkthroughs, assessing facility conditions, equipment, personnel practices, aseptic technique, and production documentation.
- Observe manufacturing activities and provide real-time coaching, quality guidance, and support to operators and production leadership.
- Identify, document, and escalate potential quality concerns, compliance gaps, and operational risks while supporting appropriate corrective actions.
- Participate in deviation investigations, root cause analysis, RAPID event responses, and change control activities.
- Review and approve manufacturing documentation, batch records, procedures, training materials, and quality records as assigned.
- Collaborate with Manufacturing, Quality, and site leadership to troubleshoot process and equipment issues and identify practical, compliant solutions.
- Support targeted quality oversight initiatives, continuous improvement activities, and ongoing inspection readiness across manufacturing operations.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Microbiology, Technology, or a related technical field is preferred.
- Minimum of four years of relevant experience in Quality Assurance, Quality Control, manufacturing operations, or a related technical environment.
- Experience in pharmaceutical manufacturing, sterile operations, aseptic processing, or another regulated industry is strongly preferred.
- Working knowledge of cGMP, FDA regulatory requirements, and quality systems.
- Familiarity with evolving EU GMP Annex 1 expectations is preferred.
- Understanding of aseptic processing, gowning requirements, and manufacturing-floor quality oversight.
- Strong analytical, troubleshooting, and problem-solving skills.
- Ability to coach employees, communicate concerns constructively, and influence others without direct supervisory authority.
- Strong interpersonal and communication skills.
- Ability to manage competing priorities and adapt to changing business needs.
- Experience with deviation investigations, root cause analysis, change control, and technical documentation is preferred.
- Strong attention to detail and organizational skills.
- Ability to stand and walk for extended periods, bend, stoop, kneel, crouch, and lift 10–35 pounds.
- Comfortable working a 12-hour rotating day-shift schedule.
Benefits
- Healthcare
- Annual incentive plan bonus
- Competitive remuneration
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.