QA Specialist II - Operations
Core
Ensuring product quality and compliance with internal procedures and external standards for clinical and commercial biopharma products.
Role type
Senior IC Quality Assurance Specialist (Operations)
Builds
Compliant clinical and commercial pharmaceutical products
Domain
Biopharma / Life Sciences / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Batch record review, Deviation investigation, CAPA management, Change control review, Risk assessment (FMEA/HACCP/PHA), cGMP compliance, FDA regulations knowledge (21CFR Part 210/211/820), Technical writing, Root cause analysis (RCA), IQ/OQ/PQ knowledge
Preferred skills
ASQ certification, Risk-based decision making, Independent thinking, Process improvement leadership
Technologies
MS Office (Word, Excel, Access, Visio), Risk Management Tools (FMEA, HACCP, PHA)
Responsibilities
Review and approve batch documentation and master batch records for product release; Manage deviation, investigation, and CAPA programs; Lead complex quality investigations and change control reviews; Develop and improve quality system procedures and specifications; Ensure site readiness for regulatory inspections.
Seniority
Senior, hands-on IC
