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 adherence to cGMP requirements and regulatory expectations.
Role type
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 knowledge, risk identification, deviation triage, SOP authoring and review, batch record review, manufacturing observation
Preferred skills
sterile drug product manufacturing experience, independent decision-making, cross-functional collaboration
Technologies
None explicitly stated
Responsibilities
Monitor process operations for compliance, make quality decisions and escalate issues, perform routine walkthroughs of manufacturing suites, enforce adherence to cGMPs and SOPs, partner with teams to triage deviation events, author and review documentation (SOPs, work instructions, batch records), ensure safe work practices, support continuous improvement initiatives
Seniority
Mid-level, hands-on IC
