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Associate Quality Control Compliance Specialist

1 month ago

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

As a key member of our quality control team, the Associate Quality Control Compliance Specialist will play a critical role in ensuring the quality and compliance of our products. This is a unique opportunity to join a dynamic team and contribute to the success of our organization.

The Associate Quality Control Compliance Specialist 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). This will involve monitoring and evaluating systems, equipment, records, and trends data, as well as reviewing and revising documentation, such as SOPs. The successful candidate will also be responsible for timely closure of QMS records, site actions, implementation of global quality standards, and validity of departmental SOPs.

Key Responsibilities
  • Perform release, stability, validation, and complaint analytical quality control tests and assays on raw materials, in-processing, and final products following GLPs
  • Perform quality control tests and assays, including USP test methods and EP test methods
  • Monitor, calibrate, maintain, and evaluate systems or equipment, such as water systems, environmental chambers, and analytical instrument/equipment
  • Analyze data and interpret results, maintaining data records in manual or computer-based logs following GDPs
  • Support QC in maintaining all records for internal and external audits following guidelines, including USFDA, Health Canada, cGMP, ISO, GLPs, company policies, and procedures
  • Support timely closure of quality management system (QMS) records, site actions, implementation of global quality standards, and validity of departmental SOPs, using 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 product
  • 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 Conditions
  • Office
  • Labs with moderate noise, heat, open flame, and radiation in specific areas requiring appropriate safety equipment (i.e., gloves, lab coat, safety glasses, and respirator)
  • 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
Travel Estimate

Up to 5%

Education and Job Qualification
  • B.S. in a related scientific major required
  • Good oral and written communication skills
  • Ability to follow specific instruction and report assay results (i.e., written SOPs)
  • 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