Quality Assurance Specialist
2 days ago
Fujifilm Diosynth Biotechnologies is seeking a highly skilled Quality Assurance Analyst III to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products.
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.
- 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.
- Bachelors degree and 3+ years experience in Pharmaceutical or other regulated Industry.
- Masters Degree and 1+ years experience in Pharmaceutical or other regulated Industry.
- Certified Quality Auditor preferred.
- Excellent written and oral communication skills.
- Excellent organizational, analytical, data review and report writing skills.
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
Fujifilm Diosynth Biotechnologies is an equal opportunity and affirmative action employer. We are committed to diversity and inclusion in the workplace.
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