Quality Assurance Specialist
1 week ago
At Fujifilm, we are committed to advancing tomorrow's medicine and empowering our employees to chase the impossible. We are seeking a highly skilled Quality Assurance Analyst III to join our team in College Station, TX.
Key Responsibilities:- Review and approve basic and technical documentation, including Standard Operating Procedures, Batch Production Records, and Commissioning, qualification and validation protocols and reports.
- Draft and review internal Quality policies, procedures, and reports.
- Perform inspection of final product containers and review and/or approval of executed process records and data.
- Lead vendor, supplier, contract laboratory and client audits.
- Identify process and Quality System improvement opportunities.
- Provide daily guidance for the compliance of the QA department to national and international standards and regulations.
- Support Regulatory, client, and internal audits.
- Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups.
- High school or equivalent and 8+ years' experience in Pharmaceutical or other regulated Industry.
- Associates Degree and 5+ years' experience in Pharmaceutical or other regulated Industry.
- Bachelor's degree and 3+ years' experience in Pharmaceutical or other regulated Industry.
- Master's Degree and 1+ years' experience in Pharmaceutical or other regulated Industry.
- Certified Quality Auditor preferred.
- Degree in Biology or Chemistry preferred.
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
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