QA Operations Specialist I - Floor Support - C shift (Sunday-Wednesday 3:30pm-2am)
Core
Provide on-the-floor Quality Assurance oversight for manufacturing and visual inspection of clinical and commercial drug products in a GMP facility.
Role type
QA Operations Specialist I (Floor Support)
Builds
GMP-compliant drug products for biopharma clients
Domain
Biopharmaceutical Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work
Required skills
GMP compliance, batch record review, AQL visual inspection, root cause analysis, regulatory knowledge (FDA 21CFR), risk management tools, scientific principles application
Preferred skills
ASQ certification, lean operation excellence, ICH Q9 familiarity, risk-based decision making
Technologies
MS Office (Word, Excel), Risk Management Tools (FMEA, HACCP, PHA)
Responsibilities
Perform real-time QA oversight of formulation and aseptic processes, conduct AQL visual inspection of finished drug product vials, review and approve GMP documentation and batch records, dispose of incoming raw materials, act as first responder for on-floor quality issues, participate in nonconforming material investigations and root cause analysis, review environmental and utility monitoring data, create and approve final product labels.
Seniority
Entry-level to Mid-level, hands-on IC
