Senior QC Analyst - GMP/GLP Lab Leader & Mentor

Sun Pharmaceutical Industries; Billerica (MA); On-site; USD 75,000 - 110,000; Full time

Job summary

Sun Pharmaceutical Industries seeks a QC Analyst to perform GMP testing of raw materials, in-process and finished products, stability samples, and non-routine analyses according to established procedures.

You will monitor systems and trends, review documentation, and work under limited supervision while following SOPs and GMP standards. This role requires effective communication and leadership within the QC group.

Qualifications

• B.S. or equivalent experience.
• Excellent oral and written and interpersonal communication skills.
• Fundamental knowledge of chemical principles and analytical instrumentation.
• Ability to follow specific instruction (i.e. written SOPs)
• Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests)
• Proficient knowledge of laboratory instrumentation (theory, function, troubleshooting)
• Strong analytical skills with attention to detail
• Able to troubleshoot and repair complex instrumentation
• Proficient computer skills including word processing, spreadsheet, and instrumentation control software programs
• Able to perform standard and non-standard analytical techniques to analyze product
• Proficient in use of Balances, UV/VIS, Conductivity Meter, TOC Meter, pH Meter, Autotitrator, Karl Fischer Titrator, HPLC, GC

Responsibilities

• Perform release, stability, validation, analytical QC tests and assays on raw materials, in-processing and final products per GLPs
• Conduct, document and follow up on assay issues, failures and complaint investigations (Trackwise)
• Calibrate, monitor, maintain and evaluate systems and equipment (water systems, environmental chambers, analytical instruments)
• Maintain data logs following GDPs and revise GMP documentation as required
• Develop, author, and execute instrument IQ/OQ and PQ protocols
• Maintain major laboratory programs (calibration, reference standards)
• Serve as liaison to service, calibration and technical representatives
• Train junior analysts on laboratory tests and lab processes
• Perform monthly equipment/instrument maintenance and cleaning
• Follow workflow procedures from receiving samples to waste disposal
• Train towards Visual Inspection qualifications
• Other duties as assigned

Skills

Excellent communication skills

Analytical skills

Troubleshooting

Computer skills

Follow SOPs

Education

B.S. or equivalent experience

Tools

Trackwise

Novatech

Empower

HPLC

GC

UV/VIS

Job description

Sun Pharmaceutical Industries seeks a QC Analyst to perform GMP testing of raw materials, in-process and finished products, stability samples, and non-routine analyses according to established procedures.

You will monitor systems and trends, review documentation, and work under limited supervision while following SOPs and GMP standards. This role requires effective communication and leadership within the QC group.