QA Specialist III (QOTF) - 12 Hour Days (2-2-3 shift)

Thermo Fisher Scientific•Greenville, NC

12d•Onsite

About The Position

The QA Specialist III – Quality on the Floor (QOTF) supports sterile pharmaceutical manufacturing at Thermo Fisher Scientific’s Greenville, North Carolina site. The position is part of Manufacturing Quality Assurance and works alongside Manufacturing, Operations, and Quality leadership to maintain regulatory compliance, strengthen aseptic practices, and support continuous improvement. Approximately 60–75% of the workday is spent on the manufacturing floor observing operations, providing guidance, and supporting real-time quality decisions. The role provides quality oversight of sterile manufacturing, filling, packaging, and inspection activities. It involves assessing operations and documentation, coaching personnel, identifying and escalating quality concerns, and contributing to investigations and process improvements. The specialist also helps maintain inspection readiness and works across teams to find practical, compliant solutions. The position is based in Greenville, NC, and follows a 12-hour rotating day-shift schedule from 6:00 AM to 6:00 PM on a 2-2-3 rotation. Work takes place in sterile manufacturing areas, including classified cleanrooms and other controlled environments, with required gowning and PPE. Employees must follow facility cleanroom restrictions, which include limits on items such as hair products, jewelry, makeup, nail polish, perfume, exposed piercings, and facial hair.

Requirements

At least four years of relevant experience in Quality Assurance, Quality Control, manufacturing operations, or a related technical environment.
Working knowledge of cGMP, FDA regulatory requirements, and quality systems.
Understanding of aseptic processing, gowning requirements, and manufacturing-floor quality oversight.
Strong analytical, troubleshooting, and problem-solving skills, including the ability to make sound, risk-based quality decisions.
Ability to coach employees, communicate concerns constructively, and influence others without direct supervisory authority.
Strong interpersonal and communication skills and ability to build productive relationships across Operations and Quality.
Ability to manage competing priorities, adapt to changing business needs, and respond effectively to urgent quality concerns.
Strong attention to detail, organizational skills, and commitment to regulatory compliance and inspection readiness.
Ability to stand and walk for extended periods and periodically bend, stoop, kneel, crouch, and move throughout manufacturing areas.
Ability to lift and move materials weighing approximately 10–35 pounds; the supplied work-schedule/environment details also state the ability to lift 40 pounds without assistance.
Comfort working a 12-hour rotating day-shift schedule and maintaining a consistent presence in active manufacturing operations.
Compliance with aseptic and non-aseptic gowning, designated PPE, cleanroom restrictions, and established safety and facility procedures.

Nice To Haves

Bachelor’s degree in Engineering, Life Sciences, Microbiology, Technology, or a related technical field; equivalent combinations of education, training, and relevant work experience may be considered.
Experience in pharmaceutical manufacturing, sterile operations, aseptic processing, or another regulated industry.
Transferable quality experience from regulated manufacturing industries, including automotive or ISO-regulated environments.
Familiarity with evolving EU GMP Annex 1 expectations.
Experience with deviation investigations, root cause analysis, change control, and technical documentation.

Responsibilities

Perform routine Quality Assurance oversight of sterile manufacturing, filling, packaging, and inspection activities for compliance with cGMP requirements and site procedures.
Conduct documented manufacturing-floor walkthroughs to assess 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, and support 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.