QC Chemist III, Raw Materials

Position Summary –

The Quality Control Raw Materials Chemist III ensures that testing, data review, and documentation is compliant with GMP regulations, internal procedures, and applicable compendial requirements. The position will be operating within a GMP environment for a Quality Control CDMO. The ideal candidate will additionally possess superior communication skills, presenting to internal and potentially external clients.

• Perform testing of raw materials, packaging components, and other samples.
• Author or act as author for lab investigations, analytical testing methods, deviations, protocols and SOPs for raw materials and raw material instrumentation.
• Provide technical support to the laboratory for method and instrument troubleshooting as needed.
• Lead the Raw Materials laboratory implementation project by overseeing installation, qualification, and training on new instruments and techniques.
• Provide training for other analysts for raw materials testing.
• Schedule the QC laboratory Raw Materials workload appropriately to meet manufacturing release testing schedules and timelines.
• Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks.
• Oversight for review of QC Raw Material data for compliance with specifications and regulatory requirements.
• Interact with third party laboratories for any microbial and analytical testing of raw materials.
• Generate and/or review shipping paperwork for third party 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.
• Other duties as assigned.