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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…
Oversees end-to-end New Product Introduction (NPI) programs in pharmaceutical manufacturing, coordinating tech transfer, validation, and commercial handoffs while managing budgets, risks, and cross-functional teams to ensure compliance with cGMP and FDA standards.
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.
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.
Design, optimize, and maintain pharmaceutical fill-finish equipment; troubleshoot issues and lead validation to ensure compliant, efficient production.
Designs, develops, and maintains automation systems for biopharmaceutical manufacturing, including PLC/HMI programming and validation under GAMP 5 and 21 CFR Part 11.
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