Manufacturing Quality Assurance Specialist
Core
Hands-on partner to manufacturing teams ensuring production meets quality, compliance, and scientific rigor standards from shop floor to product release.
Role type
Manufacturing Quality Assurance Specialist
Builds
Compliant clinical and commercial biomanufacturing products
Domain
Biopharmaceutical manufacturing (viral gene therapies, orphan diseases)
Required skills
GMP compliance, deviation investigation, batch record review, regulatory audit support, data integrity analysis, root cause analysis, SOP authoring, trend analysis, aseptic filling oversight, upstream/downstream process support
Preferred skills
Viral gene therapy experience, internal audit leadership
Technologies
Electronic records systems, GMP documentation platforms
Responsibilities
Provide proactive quality oversight through shop floor presence and walkthroughs; Review and approve master and executed batch records; Partner with manufacturing teams to ensure GMP-aligned processes; Support media, buffer, cell expansion, upstream, downstream, and aseptic filling operations; Lead deviation and corrective action investigations; Review alarms, data integrity, and electronic records; Support internal and external audits and regulatory readiness; Provide expertise in batch record design and continuous improvement; Analyze quality metrics and communicate insights; Lead or contribute to quality system enhancement projects.
Seniority
Mid-Senior, hands-on IC
