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Quality Assurance Specialist III
4 weeks ago
We are seeking a highly skilled Quality Assurance Specialist III to join our team at FUJIFILM Diosynth Biotechnologies. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our pharmaceutical 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.
- 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.
- 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 multitask and easily prioritize your work.
- Ability to work independently with little supervision.
- Proficient in Microsoft Excel, Word and PowerPoint.
- All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
At FUJIFILM Diosynth Biotechnologies, we offer a competitive salary and benefits package, as well as opportunities for professional growth and development. We are an equal opportunity employer and welcome applications from diverse candidates.
