Quality Assurance Specialist
4 weeks ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at FUJIFILM Diosynth Biotechnologies. As a Quality Assurance Specialist, you will be responsible for reviewing and approving basic and technical documentation, drafting and reviewing internal Quality policies and procedures, and assisting in and performing product-related activities.
Key Responsibilities- Review basic and technical documentation, including Standard Operating Procedures, Analytical Methods, Disposition certificates, Batch Production Records, Corrective Action/Preventive Action Plans, QC Data review, Technical Data Review, and Drug Substance/Product Reports.
- Review internal Quality policies, procedures, and reports.
- Assist in and perform Quality audit functions, including audit of lab notebooks, audit of equipment logbooks, and acting as a QA liaison to internal Departments and Vendor/Contract Laboratory Quality Groups.
- Notify Supervisor of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Master's degree in a related science concentration with 1+ year of experience of cGMP supporting pharmaceutical or biotechnology products; OR Bachelor's degree in a related science concentration with 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products; OR Associate's degree in a related science concentration with 4+ years of experience in a regulated industry, including 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products.
- ASQ Certification 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 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 Excel, Word, and PowerPoint.
- All candidates will have a working knowledge of cGMP regulations for the production of drug, biologics, or vaccine products.
FUJIFILM Diosynth Biotechnologies is a leading biotechnology company that is advancing tomorrow's medicine. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.
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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