QC Chemist III, Raw Materials

MedPharm; Durham (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

A pharmaceutical company in North Carolina seeks a QC Chemist III to ensure compliance in the testing and documentation of raw materials. This role involves performing tests, authoring investigations, and interacting with third-party labs. Candidates must possess strong communication skills and have experience in a GMP environment. This is a full-time position offering senior level responsibilities.

Qualifications

• Experience in Quality Control within a GMP environment.
• Ability to lead projects and provide technical support.
• Strong organizational skills for scheduling laboratory workloads.

Responsibilities

• Perform testing of raw materials and packaging components.
• Author lab investigations and review data for compliance.
• Interact with third party laboratories for testing.

Skills

Testing of raw materials

Communication skills

Analytical testing methods

Troubleshooting

Job description

QC Chemist III, Raw Materials – MedPharm

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

Essential Functions

• 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.

Seniority Level

Mid-Senior level

Employment Type

Full-time