QA Specialist III (QOTF) - 12 Hour Days (2-2-3 shift)
Core
Hands-on Quality Assurance oversight of sterile pharmaceutical manufacturing operations, ensuring compliance with cGMP and supporting real-time quality decisions on the production floor.
Role type
Senior IC Quality Assurance Specialist (Manufacturing)
Builds
Sterile injectable and oral solid dose drug products
Domain
Pharmaceutical manufacturing / Life Sciences
Required skills
cGMP knowledge, aseptic processing, deviation investigations, root cause analysis, change control, regulatory compliance, manufacturing floor oversight, risk-based decision making
Preferred skills
EU GMP Annex 1 familiarity, sterile operations experience, ISO-regulated environment experience, pharmaceutical manufacturing experience
Technologies
None stated
Responsibilities
Perform routine QA oversight of sterile manufacturing, filling, packaging, and inspection activities; Conduct documented manufacturing-floor walkthroughs assessing facility conditions and aseptic techniques; Observe activities and provide real-time coaching to operators; Identify and escalate quality concerns and compliance gaps; Participate in deviation investigations and root cause analysis; Review and approve manufacturing documentation and batch records.
Seniority
Senior, hands-on IC