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

Work Schedule

12 hr shift/days

Environmental Conditions

Able to lift 40 lbs. without assistance, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

COMPANY INFORMATION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .

Job Title: QA Specialist III – Quality on the Floor (QOTF)

• Location: Greenville, NC
• Schedule: Day Shift | 6:00 AM – 6:00 PM | 2-2-3 Rotating Schedule

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Greenville, NC

As part of the Drug Product Division (DPD), our Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus supporting sterile injectable and oral solid dose drug products from development through commercialization.

This position supports sterile pharmaceutical manufacturing within our Manufacturing Quality Assurance organization. The Quality on the Floor (QOTF) team works directly alongside Manufacturing, Operations, and Quality leadership to maintain regulatory compliance, strengthen aseptic practices, and support continuous improvement.

Unlike traditional desk-based Quality Assurance positions, this role requires a significant manufacturing-floor presence, with approximately 60–75% of the workday spent observing operations, providing guidance, and supporting real-time quality decisions.

How will you make an impact?

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.

You'll help maintain a state of inspection readiness by conducting routine manufacturing walkthroughs, evaluating documentation and operational practices, and supporting investigations, deviations, and process improvements.

Success in this role requires more than technical quality knowledge. You'll need strong judgment, problem-solving abilities, and the interpersonal skills to coach employees, influence decisions, and navigate operational challenges while maintaining established quality standards.

This is an excellent opportunity for an experienced Quality professional or manufacturing specialist seeking to transition into a hands-on Quality Assurance role with direct operational impact and opportunities for professional growth.

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.

Education

• •Bachelor's degree in Engineering, Life Sciences, Microbiology, Technology, or a related technical field is preferred.
• •Equivalent combinations of education, training, and relevant work experience may be considered.
• •Candidates with substantial hands-on manufacturing or quality experience who do not hold a four-year degree are encouraged to apply.

Experience

• •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.
• •Candidates with transferable quality experience from other regulated manufacturing industries, including automotive or ISO-regulated environments, may also be considered.

Individuals with strong operational knowledge, practical troubleshooting capabilities, and experience supporting quality or compliance activities on the manufacturing floor are particularly encouraged to apply.

Knowledge, Skills and Abilities

• •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 with 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 with the 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.
• •Experience with deviation investigations, root cause analysis, change control, and technical documentation is preferred.
• •Strong attention to detail, organizational skills, and commitment to maintaining regulatory compliance and inspection readiness.

Physical Requirements / Work Environment

This position requires significant time working within sterile pharmaceutical manufacturing areas, including classified cleanrooms and other controlled environments.

Employees must be able to stand and walk for extended periods, periodically bend, stoop, kneel, crouch, and move throughout manufacturing areas. The position may require lifting and moving materials weighing approximately 10–35 pounds.

The role requires appropriate aseptic and non-aseptic gowning, use of designated personal protective equipment, and compliance with established safety and facility procedures.

Candidates mus