Senior Specialist, QA (Mfg Support)
Core
Coordinate lot disposition, product release, and quality oversight for a multi-product cGxP contract manufacturing facility.
Role type
Senior QA Specialist (Manufacturing Support)
Builds
Pharmaceutical products for global customers
Domain
Biopharmaceutical manufacturing / GMP
Required skills
GMP compliance, Quality Management Systems, Root Cause Analysis, CAPA implementation, batch record review, deviation investigation, data analysis, regulatory audit support
Preferred skills
Cross-functional collaboration, process improvement, stakeholder management
Technologies
GMP, SOPs, cGxP
Responsibilities
Coordinate lot disposition and product release activities; Review and approve SOPs, protocols, and batch records; Provide real-time quality guidance on manufacturing floor activities; Oversee CAPA implementation and deviation investigations; Analyze data to resolve quality issues and recommend process improvements; Participate in manufacturing walkdowns and regulatory audits.
Seniority
Senior, hands-on IC
