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Quality Assurance Specialist
2 months ago
The Quality Assurance Specialist, QC Compliance is a critical member of our Quality team, responsible for ensuring the highest standards of quality in our laboratory processes. This role requires a strong understanding of regulatory requirements and industry best practices.
Key Responsibilities- Provide QA oversight and support for project deliverables in accordance with governing processes and procedures.
- Assess the impact of system and process modifications and maintain oversight of change management processes.
- Provide oversight and approval of laboratory system and process lifecycle documentation.
- Generate, review, and approve QA procedures and processes for operational readiness objectives.
- Ensure project and operational quality objectives are met within desired timelines.
- Collaborate with other project teams and QA departments to align strategies and procedures.
- Bachelor's degree in Life Sciences or Engineering with 2+ years of experience, or Master's degree in Life Sciences or Engineering with 1+ year of experience.
- 1+ years of experience in GMP Quality Assurance and/or a similar role.
- Experience in validation, cGMP manufacturing operations, and/or Quality oversight in an FDA-regulated facility.
- Prior experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl, and/or Kneat validation software.
- Basic experience or understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies.
- Prior experience or understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11.
- Ability to stand for prolonged periods of time up to 30 minutes.
- Ability to sit for prolonged periods of time up to 120 minutes.
- Ability to conduct work that includes moving objects up to 10 pounds.
Fujifilm is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.
