Sr. Quality Assurance Specialist
Core
Manages batch record review and release activities, ensuring compliance with GMPs for manufacturing and finished products in the pharmaceutical/biologics industry.
Role type
Senior Quality Assurance Specialist (Manufacturing/Regulatory)
Builds
Ensures release of manufactured products (small molecules and biologics) and maintains quality systems.
Domain
Pharmaceutical manufacturing / Biologics / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Batch record review and release, Parenteral and aseptic operations, Annex 1 requirements, Risk assessments, SOP authoring and review, GMP compliance, Regulatory agency interaction, Deviation and CAPA management, Change management
Preferred skills
Medical device experience, Biological product experience, Advanced degree (Masters/PhD/PharmD)
Technologies
HACCP, FMEA
Responsibilities
Manage batch record review and release; Participate in new product introductions; Conduct risk assessments; Author and review controlled documents; Prepare for site inspections; Participate in internal and external audits; Support continuous improvement initiatives; Partner on quality issue resolution; Review/approve Deviations, CAPAs, and Change Management records.
Seniority
Senior, hands-on IC
