Senior QC Analyst: GMP/GLP Analytics Lead

Sun Pharmaceutical Industries, Inc.; Billerica (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. (USA) is seeking a QC Analyst to perform GMP testing of raw materials, in-process and finished products, following established procedures. The role includes monitoring data, reviewing documentation, and working under limited supervision.

You will calibrate and maintain systems, develop IQ/OQ/PQ protocols, and mentor junior analysts while ensuring cGMP compliance and contributing to continuous improvement in QC operations.

Qualifications

• B.S. or equivalent degree in chemistry or related field.
• Excellent oral and written and interpersonal communication skills.
• Fundamental knowledge of chemical principles and analytical instrumentation.
• Ability to follow SOPs and instructions precisely.
• Proficient with wet chemical methods and instrumentation (USP/EP).
• Proficient computer skills (word processing, spreadsheets, instrumentation software).
• Able to troubleshoot analytical instruments and maintain calibration programs.

Responsibilities

• Perform release, stability, validation, and QC tests on raw materials, in-process, and final products per GLPs.
• Perform QC tests and assays using USP and EP methods.
• Document and follow up on assay issues and investigations (Trackwise).
• Calibrate, monitor, maintain, and evaluate laboratory systems and equipment.
• Maintain data logs in compliance with GDPs and cGMP."
• Develop, author, and execute IQ/OQ and PQ protocols for instruments.
• Provide mentoring and training to junior analysts.
• Lead monthly equipment maintenance and participate in lab inspections.

Skills

Oral and written communication

Interpersonal communication

Analytical instrumentation knowledge

Wet chemistry methods

HPLC/GC

Education

Bachelor's degree in Chemistry or related

Tools

Trackwise

Novatech

Empower

Job description

Sun Pharmaceutical Industries, Inc. (USA) is seeking a QC Analyst to perform GMP testing of raw materials, in-process and finished products, following established procedures. The role includes monitoring data, reviewing documentation, and working under limited supervision.

You will calibrate and maintain systems, develop IQ/OQ/PQ protocols, and mentor junior analysts while ensuring cGMP compliance and contributing to continuous improvement in QC operations.