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Quality Assurance Specialist I
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Quality Assurance Specialist
2 months ago
We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at FUJIFILM Corporation. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our pharmaceutical and biotechnology products.
Key Responsibilities- Assist in the review and approval of basic and technical documentation, including Standard Operating Procedures, Corrective Action/Preventive Action Plans, and Data Reports.
- Assist in the review of internal quality policies, procedures, and reports.
- Assist in the inspection of final product containers and review and/or approval of executed process records and data.
- Participate in Quality audits, including the audit of 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.
- 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.
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.
- Experience prolonged sitting, some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Lifting up to 25 pounds on occasion.
- Ability to wear restrictive gowning for extended periods of time during periods of prolonged standing.
FUJIFILM Corporation is a global leader in the development and manufacturing of pharmaceutical and biotechnology products. We are committed to advancing tomorrow's medicine and empowering our employees to chase the impossible. 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.
