Quality Assurance Specialist
4 weeks ago
We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at FUJIFILM Diosynth Biotechnologies. The successful candidate will be responsible for assisting with the review and approval of basic and technical documentation, drafting and reviewing internal Quality policies and procedures, and assisting with product-related activities.
Key Responsibilities:- Assist with the review of basic documentation, including Standard Operating Procedures, Corrective Action/Preventive Action Plans, and Data Reports.
- Assist with the review of internal quality policies, procedures, and reports.
- Assist with the inspection of final product containers and review and/or approval of executed process records and data.
- Assist in Quality audits, including the audit of lab notebooks, audit of equipment logbooks, and review of 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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Quality Assurance Specialist
3 weeks ago
College Station, Texas, United States FUJIFILM Corporation Full timeJob Title: Quality Assurance SpecialistAt FUJIFILM Diosynth Biotechnologies, we are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities:Assist with the review and approval of...
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Quality Assurance Specialist
3 weeks ago
College Station, Texas, United States FUJIFILM Corporation Full timeJob DescriptionAt FUJIFILM Diosynth Biotechnologies, we are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities:Assist with the review and approval of basic and technical...
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College Station, Texas, United States FUJIFILM Corporation Full timeJob SummaryWe 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...
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Quality Assurance Specialist
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College Station, Texas, United States FUJIFILM Corporation Full timeJob DescriptionAt FUJIFILM Diosynth Biotechnologies, we are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. The successful candidate will be responsible for assisting with the review and approval of basic and technical documentation, drafting and reviewing internal Quality policies and procedures, and assisting...
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College Station, Texas, United States FUJIFILM Diosynth Biotechnologies Full timeThe Quality Assurance Specialist will be responsible for reviewing and approving documentation, drafting and reviewing quality policies and procedures, and assisting in product-related activities. This role will also involve performing quality audit functions, identifying process and quality system improvements, and acting as a liaison internally.Key...
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