Associate, Quality Control Specialist

14 hours ago

Billerica, Massachusetts, United States Sun Pharma 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. The successful candidate will perform various quality control tests on raw materials, in-process, and final products using approved test methods and Standard Operating Procedures (SOPs). They will also monitor and evaluate systems, equipment, records, and trends data, and review and revise documentation as needed.

Responsibilities
  • Perform release, stability, validation, and complaint analytical quality control tests and assays on raw materials, in-process, and final products following GLPs.
  • Perform quality control tests and assays, including USP and EP test methods.
  • Monitor, calibrate, maintain, and evaluate systems or equipment, such as water systems, environmental chambers, and analytical instrumentation.
  • Analyze data and interpret results, maintaining data records in manual or computer-based logs following GDPs.
  • Support QC in maintaining all internal and external audits, following guidelines including USFDA, Health Canada, cGMP, ISO, GLPs, company policies, and procedures.
  • Assure timely closure of quality management system (QMS) records, site actions, implementation of global quality standards, and validity of departmental SOPs.
  • Use Trackwise to create, populate, investigate, and close event records (OOS, CAPA, UPD, PD, CC, etc.).
  • Send samples to contract laboratories and collect test data.
  • Wash glassware, prepare reagents, solutions, 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.
Work Environment

The Associate Quality Control - Compliance role will be based in a laboratory setting with moderate noise, heat, open flame, and radiation in specific areas requiring appropriate safety equipment. The successful candidate will work with non-hazardous and hazardous chemicals, toxic metals, cryogenic gases, and radioactive materials. They will also be required to wear Personal Protection Equipment and work in chemical fume hoods and clean rooms.

Requirements
  • B.S. in a related scientific major required.
  • Good 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 related experience. Use of Trackwise, Novatech, and Empower software is required.

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