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The QA Specialist II provides on-the-floor quality oversight for manufacturing and visual inspection activities in a GMP facility. This role involves ensuring compliance with regulatory standards, reviewing batch records, and managing quality investigations for drug product production.
The QA Operations Specialist II provides on-the-floor quality oversight for manufacturing and visual inspection activities in a GMP facility. This role involves batch record review, compliance monitoring, and supporting investigations to ensure adherence to regulatory standards.
Performs visual inspection and quality checks on biopharma products during manufacturing to ensure GMP compliance and patient safety.
Review batch records, approve investigations, and ensure GxP compliance for biopharma manufacturing, shaping quality systems for clinical and commercial products.
Perform real-time GMP quality assurance for biopharma manufacturing, including floor oversight, batch record review, AQL inspections, and issue resolution to ensure regulatory compliance and patient safety.
Coordinates review and approval of GMP documents using an electronic system, manages archival, and interfaces with authors to meet timelines in a biopharma services role.
Monitors aseptic manufacturing processes in cleanroom environments to ensure compliance with quality standards, documenting behaviors and escalating deviations to maintain product safety and patient outcomes.
Review batch records, approve investigations, and ensure GxP compliance for biopharma manufacturing, supporting clinical and commercial product release.
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our…
Performs quality assurance tasks in a biopharma contract manufacturing environment, reviewing documentation, inspecting products, and ensuring cGMP compliance.
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