Specialist, Manufacturing QA
Core
Ensuring product quality and regulatory compliance for marketed and investigational drug products in a sterile manufacturing environment.
Role type
Manufacturing QA Compliance Specialist
Builds
Compliant drug products for end users and regulatory authorities
Domain
Pharmaceutical / Biologics / Sterile Manufacturing
Deliverable
physical/clinical work
Required skills
Regulatory requirements knowledge, Batch record review, Manufacturing log review, SOP/JSTM/Risk Assessment review, Line Clearance, Incoming Raw Material checks, Stability Program support, Finished product status maintenance, Quality log administration, Manufacturing area walkarounds, Continuous improvement processes
Preferred skills
Biologics experience
Technologies
None stated
Responsibilities
Document and establish quality systems, Assess and report on quality system effectiveness, Provide quality oversight during aseptic processing, Lead or assist in non-compliance investigations, Review completed batch records, Conduct line clearance activities, Perform incoming raw material checks, Support stability programs, Maintain finished product status and labeling, Administer quality logs, Lead daily manufacturing floor walkarounds, Drive continuous improvements
Seniority
Mid-level, hands-on IC
