Quality Assurance Operations Specialist
Core
Provide QA support for shopfloor GMP-related activities, ensuring timely batch release and regulatory compliance.
Role type
Quality Assurance Operations Specialist
Builds
Compliant pharmaceutical batches and quality documentation
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP quality systems knowledge, regulatory requirements awareness, documentation lifecycle management, deviation investigation, CAPA support, batch record review, material release, calibration support
Preferred skills
Radiation, PET, or radiopharmaceuticals experience
Technologies
None stated
Responsibilities
Prepare and perform QA review of batch release documentation, provide on-site QA support for shopfloor GMP activities, ensure compliant documentation lifecycle management, review and release starting materials and incoming goods, review and approve quality-related documentation, support deviation and investigation activities, support CAPA and change control activities
Seniority
Individual Contributor
