Associate, Quality Control

21 hours ago


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

The Associate Quality Control - Compliance role is a dual function position that combines quality control compliance activities with laboratory GMP testing activities. The successful candidate will be responsible for performing various quality control tests on raw materials, in-process, and final products using approved test methods, Standard Operating Procedures (SOPs), and adhering to current Good Manufacturing Practices (cGMPs). This role requires a strong analytical mindset, attention to detail, and excellent communication skills.

Key Responsibilities
  • Perform release, stability, validation, and complaint analytical quality control tests and assays on raw materials, in-process, and final products following Good Laboratory Practices (GLPs).
  • Conduct quality control tests and assays, including USP and EP test methods, to ensure compliance with regulatory requirements.
  • Monitor, calibrate, maintain, and evaluate systems or equipment, such as water systems, environmental chambers, and analytical instrumentation.
  • Analyze data and interpret results, maintaining accurate records in manual or computer-based logs following Good Distribution Practices (GDPs).
  • Support quality control activities for internal and external audits, adhering to guidelines from regulatory bodies, including the US FDA, Health Canada, cGMP, ISO, GLPs, and company policies and procedures.
  • Ensure timely closure of quality management system (QMS) records, site actions, implementation of global quality standards, and validity of departmental SOPs using Trackwise software.
  • Send samples to contract laboratories and collect test data.
  • Prepare reagents, solutions, and equipment for chemical tests and assays.
  • Operate complex laboratory instrumentation to analyze products.
  • Perform monthly equipment/instrument maintenance and cleaning.
  • Follow workflow procedures from receiving test samples, monitoring inventories, to waste disposal.
  • Train towards Visual Inspection qualifications.
  • Perform other duties as assigned.
Work Environment

This role requires working in a laboratory setting with moderate noise, heat, open flame, and radiation in specific areas, necessitating the use of appropriate safety equipment.

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 25 pounds.
  • Operate computer/office machines.
  • Ability to wear Personal Protection Equipment.
Education and Qualifications
  • Bachelor's degree in a related scientific field.
  • Excellent oral and written communication skills.
  • Ability to follow specific instructions and report assay results.
  • Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.).
  • Fundamental knowledge of chemical principles.
  • Proficient with basic laboratory instrumentation.
  • Understanding of cGMPs and GLPs.
  • Strong analytical skills with attention to detail.
  • Able to perform basic troubleshooting and repair of complex instrumentation.
  • Proficient computer skills, including word processing and spreadsheet programs.
Experience
  • Minimum 2-4 years of related experience.
  • Experience with Trackwise, Novatech, and Empower software.


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