Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at FUJIFILM Diosynth Biotechnologies. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our products.
Key Responsibilities- Assist in the review and approval of documentation, including Standard Operating Procedures, Corrective Action/Preventive Action Plans, and Data Reports.
- Conduct inspections of final product containers and review executed process records and data.
- Participate in Quality audits, including lab notebooks, equipment logbooks, and vendor, supplier, contract laboratory audit questionnaires.
- Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Bachelor's degree in a related science concentration with some experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
- Associate's degree in a related science concentration with 2+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
- High School Diploma or GED with 4+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products required.
- ASQ Certification preferred.
- Knowledge of GMP/GLP regulations preferred.
- Excellent written and oral communication skills.
- Excellent organizational, analytical, data review and report writing skills.
- Ability to set personal performance goals and provide input to departmental objectives.
- Ability to adapt to frequent and rapid changes in the work environment and allocate, adjust and optimize time accordingly.
- Ability to work independently and establish work priorities to meet targets and timelines.
- Proficient in Microsoft Office.
- All candidates will have a working knowledge of cGMP regulations to produce drug, biologics, or vaccine products.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.
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