Quality Control Analyst

About the role

We are seeking a highly motivated Quality Control Analyst to join the QC laboratory at our Monroe manufacturing facility. Reporting to the QC Manager, you will ensure analytical testing is performed in strict compliance with cGMP and USFDA regulations, supporting the production of high‑quality pharmaceutical products.

Key responsibilities

• Conduct QC analysis of raw materials, in‑process, finished product and stability samples following cGMP standards.
• Maintain data integrity and perform instrument qualification (IOQ) and calibration under guidance of CQA.
• Execute and document procedures for RM, PM, FD testing, swab sampling and technology transfer of analytical methods.
• Provide data for stability studies and support cleaning validation for new products.
• Act as a qualified trainer for QC systems and SOPs, ensuring staff are properly trained.
• Monitor reagent usage, control costs and contribute to budget‑related resource planning.
• Implement CAPA for out‑of‑specification results and update SOPs, specifications and related documents.
• Prepare the laboratory for internal and external audits and ensure ongoing compliance with regulatory updates.

Required profile

• Strong knowledge of cGMP and USFDA requirements for pharmaceutical QC.
• Experience working in a regulated QC laboratory environment.
• Ability to train and mentor laboratory personnel.
• Detail‑oriented with a focus on data integrity and cost efficiency.
• Excellent communication skills to report findings and coordinate with supervisors.

Required skills

• cGMP compliance
• Instrument qualification and calibration (IOQ)
• Analytical testing of raw material, in‑process and finished product
• Stability study data handling
• Technology transfer of analytical methods
• Cleaning validation
• CAPA implementation
• SOP development and revision