Senior QC Analyst

Sun Pharmaceutical Industries Ltd•Billerica, MA

About The Position

Performs GMP testing of raw materials, in-process and finished products, stability samples, and non-routine samples using established procedures and methodologies. Monitors and evaluates systems, equipment, records, and trends data; reviews and revises documentation such as SOPs; and works under limited supervision while following established procedures. The role conducts release, stability, validation, and analytical quality control testing, maintains laboratory programs and equipment, investigates assay issues and failures, supports GMP compliance, and serves as a leader and knowledge resource within the QC group. It also provides mentoring and training to junior analysts.

Requirements

B.S. degree or equivalent experience.
Excellent oral, written, and interpersonal communication skills.
Fundamental knowledge of chemical principles and analytical instrumentation.
Ability to follow specific instructions, including written SOPs.
Proficiency with wet chemical methods and tests, including USP, ACS, titration, and limit tests.
Proficient knowledge of basic and complex laboratory instrumentation, including theory, function, and basic and complex troubleshooting.
Strong analytical skills and attention to detail.
Ability to troubleshoot and repair complex instrumentation.
Proficient computer skills, including word processing, spreadsheets, and instrumentation control software programs.
Ability to perform standard and non-standard analytical techniques to analyze products.
Proficiency using balances, UV/VIS spectrometers, conductivity meters, TOC meters, pH meters, autotitrators, Karl Fischer titrators, high-temperature furnaces and ovens, fume hoods, stirrer/hot plates, propane burners, compressed gas regulators and cylinders, melting point equipment, IR, gamma ray spectrometers and RCP assays, flame atomic absorption (AA), polarographs, osmometers, HPLC, and GC.
Minimum 5–7 years of related experience.
Experience using Trackwise, Novatech, and Empower software.
Experience with qualitative and quantitative analysis using good analytical laboratory practices.
Working knowledge of cGMP/GLP.
Ability to wear personal protective equipment.
Ability to lift up to 25 lbs.

Responsibilities

Perform release, stability, validation, and analytical quality control tests and assays on raw materials, in-process materials, and final products following GLPs.
Perform quality control tests and assays using USP and EP test methods.
Conduct, document, and follow up on assay issues, failures, and complaint investigations using Trackwise.
Calibrate, monitor, maintain, and evaluate systems and equipment, including water systems, environmental chambers, and analytical instruments and equipment.
Maintain data in manual or computer-based logs following GDPs.
Develop, author, and execute instrument IQ/OQ and PQ protocols.
Maintain major laboratory programs, including calibration and reference standard programs.
Serve as liaison to service, calibration, and technical representatives.
Send samples to contract laboratories and collect test data.
Wash glassware and prepare reagents, solutions, and equipment for chemical tests and assays.
Maintain the laboratory in cGMP compliance and conduct internal laboratory inspections.
Record and review GMP data; monitor and evaluate QC systems and equipment; recommend procedural improvements; and revise GMP documentation as required.
Serve as a leader within the QC group and a knowledge resource within the company.
Mentor and train junior analysts on laboratory tests, skills, and processes.
Perform monthly equipment and instrument maintenance and cleaning.
Follow workflow procedures for receiving test samples, monitoring inventories, and waste disposal.
Train toward Visual Inspection qualifications.
Perform other duties as assigned.