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Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Insight Global. As a key member of our quality assurance team, you will be responsible for providing QA oversight for the qualification of equipment, facilities, utilities, analytical instruments, and computerized systems.
Key Responsibilities- Qualification and Startup Activities: Support large capital projects as a Quality Assurance resource, ensuring compliance with regulatory requirements.
- Documentation Review and Approval: Provide QA review and approval of system lifecycle documentation, including requirements specifications, configuration specifications, risk assessments, IQ/OQ/PQ protocols, and summary reports.
- Validation Non-Conformances: Perform QA review and approval of validation non-conformances, ensuring timely resolution and compliance with regulatory requirements.
- Compliance Support: Assist in the resolution of compliance issues in partnership with process owners and subject matter experts.
- Project Support: Provide QA support for other project-related activities as necessary.
- Education: Bachelor's Degree in Engineering or Life Sciences.
- Experience: Minimum of 7 years of total combined experience in quality assurance and/or validation within a GMP regulated manufacturing environment (FDA, EMA, MHRA).
- Skills: Experience in biologics and/or gene therapy manufacturing facilities, qualification of equipment, utilities, facilities, and analytical instrumentation and computerized systems, large capital project and facility startup, QC analytical systems, current industry practices and regulatory expectations regarding qualification and validation, data integrity requirements for computerized systems, effective communication with cross-functional teams, and detailed review of GMP documents.
- Software: Experience working with eVLMS, eDMS, and CMMS.
Competitive hourly rate: $42-57/hr. Exact compensation may vary based on skills, experience, and education. Comprehensive benefit package, including medical, dental, and vision insurance, HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Paid sick leave and/or other paid time off as provided by applicable law.
