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Job Description
Quality Control Specialist (hybrid) role supporting New Material Introduction process, interacting with departments, and managing external testing Laboratories. Responsibilities include cGMP compliance, audit preparation, and Quality Risk Management. Requirements: Bachelor's degree in a science-related field, 2-4 years of cGMP laboratory experience, and knowledge of New Material Introduction process. Key Responsibilities:
- Support Quality Control Manager on cGMP and cGLP policies
- Facilitate communication for QC team representation on tier meetings
- Coordinate New Material Introduction process, supplier changes, and associated qualification
- Support selection and management of external testing Laboratories
- Participate in Internal/External Investigations
- Coordinate Quality standards for raw materials and components
- Complete impact assessments for change controls
- Support audit/inspection requirements
- Participate in internal and external audits and inspections
- Coodinate Annual Product Review
- Contribute to Quality Risk Management
- Bachelor's degree in a science-related field
- 2-4 years of cGMP laboratory experience
- Knowledge of New Material Introduction process