Senior Associate Quality Assurance
Core
Provide daily oversight of Drug Product manufacturing areas and ensure process execution aligns with regulatory requirements in a Grade 8 Clean Room facility.
Role type
Senior Associate Quality Assurance (Manufacturing)
Builds
Drug Product medicines for patients with serious illnesses
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
GMP operations, aseptic behaviors, electronic batch review, SOP revision, minor deviation evaluation, MES documentation, visual inspection
Preferred skills
Project management, quality systems experience, documentation evaluation, leadership, organizational skills
Technologies
MES, Electronic Batch Records, GMP Document Systems
Responsibilities
Perform 100% manual visual inspection, conduct QA oversight assessments, review and approve electronic maintenance documentation, evaluate compliance issues, support minor deviations, ensure quality records completion
Seniority
Mid-level, hands-on IC
