Associate Quality Control Specialist
23 hours ago
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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