Quality Assurance QA Specialist
Core
Partner with GMP operations and validation teams to ensure quality, safety, and reliability by managing quality systems, reviewing batch records, and overseeing batch release processes.
Role type
Quality Assurance Operations Specialist
Builds
Pharmaceutical manufacturing batches compliant with regulatory standards
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (batch release and quality compliance)
Required skills
Batch record review, deviation investigation, root cause analysis, CAPA management, validation documentation review, regulatory compliance (FDA/EMA), risk management, audit support, continuous improvement
Preferred skills
Engineering or Science degree, pharmaceutical industry experience, batch release expertise, GEMBA walk-down participation
Technologies
Digital batch disposition tools, validation protocols, risk assessment matrices
Responsibilities
Review and approve batch records and associated documentation; Oversee batch release process ensuring GMP compliance; Lead complex root cause investigations for deviations; Monitor and analyze batch release performance metrics; Review qualification and validation documentation; Conduct audits of production processes; Coordinate Annual Product Review (APR)
Seniority
Mid-level, hands-on IC
