Associate Quality Control Specialist

23 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 and compliance 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 current Good Manufacturing Practices (cGMPs).

Key Responsibilities
  • Perform release, stability, validation, and complaint analytical quality control tests and assays on raw materials, in-processing, and final products following Good Laboratory Practices (GLPs)
  • Monitor, calibrate, maintain, and evaluate systems or equipment, including water systems, environmental chambers, and analytical instruments
  • Analyze data and interpret results, maintaining data records in manual or computer-based logs following Good Distribution Practices (GDPs)
  • Support quality control activities for internal and external audits, following guidelines from regulatory bodies such as the US FDA, Health Canada, and ISO
  • Assure 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
  • Perform monthly equipment/instrument maintenance and cleaning
  • Follow workflow procedures from receiving test samples, monitoring inventories, to waste disposal
  • Train towards Visual Inspection qualifications
  • Other duties as assigned

Work Environment
  • Office
  • Labs with moderate noise, heat, open flame, 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
  • Requires access/work in chemical fume hoods
  • Requires access/work in class 100K, 10K, or 100 clean room (mask and boots in conformance with environmental dress codes)

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 lbs.
  • Operate computer/office machines
  • Ability to wear Personal Protection Equipment

Education and Job Qualifications
  • Bachelor's degree in a related scientific major required
  • Good oral and written communication skills
  • Ability to follow specific instruction 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 spread sheet programs

Experience
  • Minimum 2-4 years related experience
  • Use of Trackwise, Novatech, and Empower software


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