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 activities of clinical and commercial drug products in a GMP facility.
Role type
Quality Assurance Operations Specialist (Manufacturing Support)
Builds
GMP-compliant drug products for biopharma clients
Domain
Biopharmaceuticals / GMP Manufacturing
Required skills
GMP compliance, batch record review, AQL visual inspection, root cause analysis, regulatory knowledge (FDA 21CFR), risk management tools, technical writing
Preferred skills
ASQ certification, lean operation excellence, ICH regulations, FMEA/HACCP/PHA, MS Office proficiency
Technologies
MS Office (Word, Excel), GMP documentation systems
Responsibilities
Perform on-the-floor QA activities including room release and auditing critical processes; Review and approve GMP documents, SOPs, and work orders; Conduct AQL visual inspection of finished drug product vials; Support evaluation and disposition of raw materials, intermediates, and finished products; Act as first responder for on-floor quality issues and document investigations; Review environmental and utility monitoring data; Participate in root cause analysis and quality improvement initiatives.
Seniority
Entry-level to Mid-level, hands-on IC
