QC Manager, Raw Materials

The Quality Control Raw Materials Manager ensures that testing, data review, and documentation is compliant with GMP regulations, internal procedures, and applicable compendial requirements.

Requirements

• Author or act as author for lab investigations, deviations, protocols and specifications for raw materials.
• Schedule the QC laboratory Raw Materials workload appropriately to meet manufacturing release testing schedules, stability pull dates and timelines.
• Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks.
• Oversight for review of QC and Raw Material data for compliance with specifications and regulatory requirements
• Interact with third party laboratories for microbial and analytical testing of raw materials
• Generate and/or review shipping paperwork for third part testing and prepare samples for shipment.
• Create purchase requisitions for lab supplies and third-party testing
• Perform weekly laboratory audit inspections
• Perform sampling of raw materials as needed
• Review third party laboratory investigations and protocols.
• Provide technical support to the laboratory for method and instrument troubleshooting as needed.
• Lead the Raw Materials laboratory implementation project by overseeing the installation, qualification, and training on new instruments and techniques.
• May perform testing of raw materials, packaging components, and other samples as needed.
• Supervise direct reports