Quality Assurance Associate Specialist
Core
Provide essential QA oversight and support for manufacturing batch documentation, SOPs, and GMP compliance across a vaccine and biologics production facility.
Role type
Quality Assurance Associate Specialist
Builds
Manufacturing batch records, operational procedures, and quality reporting measures for vaccine and biologics supply.
Domain
Pharmaceutical manufacturing / Biologics / GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP Compliance, Documentation Review, Deviation Management, Root Cause Analysis, Quality Auditing, Regulatory Requirements, Technical Writing, Training and Development, Aseptic Filling, Complaint Management
Preferred skills
None stated
Technologies
None stated
Responsibilities
Review and approve manufacturing batch documentation and electronic batch records; Drive writing and rollout of operational procedures and training materials; Liaise with Quality Specialists to resolve batch manufacturing queries; Provide real-time on-the-floor support for area clearances and batch record reviews; Initiate and maintain quality metrics and monitor quality systems; Lead selection, development, and coaching of team members.
Seniority
Mid-level, hands-on IC