QA Specialist III (Sunday-Thursday,11p-8a)
Core
Ensuring cGMP compliance and quality standards for biologics manufacturing operations through document review, floor audits, and issue resolution.
Role type
Senior Quality Assurance Specialist (Manufacturing)
Builds
Pharmaceutical biologics products
Domain
Biologics manufacturing / Life Sciences
Deliverable
client delivery
Required skills
GMP compliance, batch record review, regulatory knowledge (US/EU), problem-solving tools, change control management, floor execution oversight
Preferred skills
Equipment/facilities qualifications knowledge, GDP knowledge, leading and directing team members
Technologies
GMP systems, QC TRF systems
Responsibilities
Verify compliance with ISO/GMP quality system requirements, perform QA walkthroughs with manufacturing groups, review and approve GMP master documents and batch records, support QA presence on the floor, manage quality records and change controls
Seniority
Senior, hands-on IC with potential leadership duties
