Senior QC Analyst: GMP Lab Leader & Compliance

SUN PHARMA; Billerica (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Fellow team members will maintain instrument calibration, support analytical method validation, and ensure compliance with cGMP regulations while collaborating across QA/QC functions.

Qualifications

• B.S. or equivalent experience in chemistry or pharmaceutical sciences.
• Strong knowledge of cGMP/GLP and QA/QC principles.
• Proficient with wet chemistry methods and instrumentation.
• Experience with TrackWise and data trend analysis.
• Excellent communication and documentation skills.

Responsibilities

• Perform GMP testing of materials and products following established procedures.
• Conduct, document and track assay issues and investigations (TrackWise).
• Calibrate, monitor, maintain and evaluate systems and equipment (lab instruments).
• Maintain data in logs and review GMP data and documentation.
• Mentor junior analysts and lead QC activities.
• Ensure cGMP compliance and participate in internal lab inspections.

Skills

cGMP knowledge

Quality control

Analytical chemistry

USP methods

TrackWise

Education

Bachelor's degree or equivalent experience in Chemistry/Pharma

Tools

TrackWise

Empower

Novatech

Job description

Fellow team members will maintain instrument calibration, support analytical method validation, and ensure compliance with cGMP regulations while collaborating across QA/QC functions.