QA specialist
Core
Inspect products and review documentation throughout the production process (manufacturing, filling, labeling) to ensure compliance with customer and regulatory requirements in a biopharma environment.
Role type
Quality Inspector (IC)
Builds
Production batches and documentation for biopharma customers
Domain
Biopharma / Healthcare manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Product inspection, documentation review, non-conformance identification, root cause analysis, regulatory compliance knowledge
Preferred skills
Quality Assurance experience in medical device/biotech/pharma, knowledge of ISO 9001/13485/21 CFR 820/11/17025/EXCiPACT
Technologies
Microsoft Outlook, Word, Excel, Access
Responsibilities
Perform pre-fill, in-process, and final inspections; document and trend quality production issues; stop production upon observing non-conformances; review production documentation for accuracy and GDP compliance; assist in event and complaint investigations; maintain audit readiness of the work area.
Seniority
Mid-level, hands-on IC
