QA Specialist III - Quality on the Floor (QOTF)

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.

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

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.

Environmental Conditions