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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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Quality Assurance Specialist II
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Quality Assurance Specialist
3 weeks ago
College Station, Texas, United States FUJIFILM Corporation Full timeJob SummaryThe Quality Assurance Analyst II 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 ResponsibilitiesReview and approve basic and technical documentation, including Standard Operating...
Senior Quality Assurance Analyst
2 months ago
The role of Senior Quality Assurance Analyst at FUJIFILM Corporation is a critical position that requires a high level of expertise in quality assurance and regulatory compliance. As a key member of the quality team, you will be responsible for ensuring that all products meet the highest standards of quality and regulatory requirements.
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.
- Perform Quality audit functions, including audit of lab notebooks, audit of equipment logbooks, and review of vendor, supplier, contract laboratory audit questionnaires.
- 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.
- Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Masters Degree and 3+ years of Pharmaceutical or other regulated Industry experience.
- Bachelors Degree and 5+ years of Pharmaceutical or other regulated Industry experience.
- Associates degree and 7+ years of Pharmaceutical or other regulated Industry experience.
- 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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, and stretching.
- Lifting up to 25 pounds on occasion.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
Attendance is mandatory.
