Quality Specialist - Validation
- Assists in the development of cGMP operating procedures that relate to process, computer
- Assures compliance with SOPs upon implementation. Investigates and proposes additional
- Communicates with Field Quality/Operations and other Operational and Quality Assurance
- Assists in ensuring validation approaches are current to regulatory expectations and
- Write test cases to validate critical control points, user requirements, and functional
- Bachelor's degree
- Work is performed in an office and a laboratory/manufacturing environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposed to occasional extreme cold below 32* and high levels of noise in production areas.
- Exposure to electrical office and laboratory equipment.
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