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Senior Associate, Quality Assurance

2 months ago

Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time

Job Summary

The Quality Assurance Specialist will be responsible for performing quality control reviews of testing records of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology.

Key Responsibilities

  • Conduct quality control reviews of testing records to ensure compliance with established procedures and methodology.
  • Oversee and continuously improve the Quality System for the QC laboratory to ensure FDA and regulatory compliance.
  • Plan, direct, and coordinate quality control batch record reviews, logbook reviews, QC test reviews, and lot disposition activities.
  • Support regulatory inspections and internal/external audits.
  • Perform reviews of release, stability, validation, analytical quality control tests on raw materials, in-process and final products.
  • Conduct, document, and follow up on Out of Specification (OOS) and Out of Trend (OOT) investigations.
  • Conduct, document, and follow up on laboratory events.
  • Review calibration, monitor, and evaluate systems and equipment, including water systems, environmental chambers, analytical instrumentation, and equipment.
  • Review IQ/OQ and PQ protocols for analytical instruments.
  • Maintain the laboratory in compliance with cGMP regulations and conduct inspections and internal audits.
  • Record and review GMP data, monitor and evaluate QC systems and equipment, recommend improvements to procedures, and revise GMP documentation as required.
  • Serve as a leader within the QC group and as a knowledge resource within the company.
  • Perform other duties as assigned.

Work Environment

  • Office and laboratory settings.
  • Exposure to noise, heat, open flames, and radiation in specific areas requiring appropriate safety equipment.
  • Work with non-hazardous and hazardous chemicals, toxic metals, cryogenic gases, and radioactive materials.
  • Exposure to or use of syringes and needles.

Physical Requirements

  • Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear and talk.
  • Close vision.
  • Lift up to 10 pounds.
  • Operate computer and office machines.

Education and Qualifications

  • Bachelor's degree or equivalent experience.
  • Excellent oral, written, and interpersonal communication skills.
  • Ability to follow specific instructions and procedures.

Experience

  • Minimum 5-7 years of related experience.
  • Working knowledge of cGMP and GLP regulations.
  • Fundamental knowledge of chemical principles and analytical instrumentation.
  • Proficient with wet chemical methods and tests.
  • Proficient knowledge of basic and complex laboratory instrumentation.
  • Competent computer skills, including Microsoft Office and instrumentation control software programs.
  • Experience with qualitative and quantitative analysis using good analytical laboratory practices.
  • Proficient in the use of various laboratory equipment, including UV/VIS spectrometers, conductivity meters, pH meters, Karl Fischer titrators, high-temperature furnaces, and ovens.