Senior Chemist - Raw Materials QC (GMP)

MedPharm; Durham (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

MedPharm is seeking a Chemist III/Sr. Chemist Raw Materials to ensure testing, data review and documentation comply with GMP, USP/EP/JP, and internal procedures in a CDMO setting.

The role emphasizes collaboration with Manufacturing Operations and Quality Assurance, with a focus on method verification and transfer for incoming raw materials. The ideal candidate has 5–8 years in analytical chemistry within a cGMP/GLP environment, strong communication skills, and experience with HPLC, GC, FTIR,

Qualifications

• Bachelor's degree in a scientific discipline required.
• Minimum 5-8 years of analytical chemistry experience in a cGMP/GLP environment.
• Experience at a CDMO or pharmaceutical company preferred.
• Experience with USP/EP/JP monographs is a plus.

Responsibilities

• Schedule QC laboratory Raw Materials workload to meet release testing schedules and timelines.
• Monitor weekly laboratory and data review activities for accuracy and hours needed.
• Review QC and Raw Materials data for compliance with specifications and regulatory requirements.
• Interact with third party laboratories for microbial and analytical testing of raw materials.
• Generate/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 and sampling of raw materials.
• Review third party laboratory investigations and protocols.
• Execute advanced chemical/instrumental testing (HPLC, GC, FTIR, UV-Vis, Karl Fischer, wet chemistry).
• Ensure testing meets compendial standards (USP/EP/JP) and regulatory expectations; peer review COAs and logs.
• Author/review GMP docs including SOPs, protocols, CAPAs, and change controls.
• Provide technical guidance to junior analysts; lead method verification/validation/transfer for incoming raw materials.
• Oversee calibration, maintenance, and troubleshooting of lab equipment.

Skills

GMP/GLP

Analytical Chemistry

HPLC/GC/FTIR

Data Review

Communication

CRO environment

Education

BA/BS in Chemistry or related field

Tools

Empower

LIMS

MS Office

HPLC

Job description

MedPharm is seeking a Chemist III/Sr. Chemist Raw Materials to ensure testing, data review and documentation comply with GMP, USP/EP/JP, and internal procedures in a CDMO setting.

The role emphasizes collaboration with Manufacturing Operations and Quality Assurance, with a focus on method verification and transfer for incoming raw materials. The ideal candidate has 5–8 years in analytical chemistry within a cGMP/GLP environment, strong communication skills, and experience with HPLC, GC, FTIR,