Quality Assurance, On-the-Floor
Core
Provide real-time on-the-floor quality oversight of manufacturing operations (Drug Substance and sterile Drug Product) to ensure cGMP compliance and operational excellence.
Role type
Senior IC Quality Assurance Specialist (Manufacturing)
Builds
Compliant manufacturing outcomes for Drug Substance and sterile Drug Product
Domain
Biopharma / Pharmaceutical Manufacturing
Deliverable
physical/clinical work
Required skills
cGMP compliance, GMP process monitoring, deviation triage, SOP authoring/review, risk identification, batch record review, safety protocols
Preferred skills
sterile drug product manufacturing experience, independent decision-making, cross-functional collaboration
Technologies
None stated
Responsibilities
Monitor process operations for regulatory compliance, perform routine walkthroughs of manufacturing suites, author and review documentation (SOPs, work instructions, batch records), triage deviation events, enforce adherence to cGMPs and SOPs, support continuous improvement initiatives
Seniority
Mid-level, hands-on IC