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Quality Assurance Specialist
1 month ago
At FUJIFILM Diosynth Biotechnologies, we are seeking a highly skilled QA Analyst II to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.
Key Responsibilities:- Review and approve basic and technical documentation, including Standard Operating Procedures, Analytical Methods, and Batch Production Records.
- Draft and review internal Quality policies and procedures.
- Assist in and perform Quality audit functions, including audits of lab notebooks and equipment logbooks.
- Act as a QA liaison to internal departments and vendor/contract laboratory quality groups.
- Notify supervisors 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 in cGMP supporting pharmaceutical or biotechnology products; OR
- Bachelor's degree in a related science concentration with 2+ years of experience in 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 in cGMP supporting pharmaceutical or biotechnology products; OR
- ASQ Certification preferred.
- Degree in Biology or Chemistry.
- 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.
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 sitting, some bending, stooping, and stretching. Ability to sit for long periods to work on a computer. Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials. Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5 gowning material and appropriate shoes required in most areas with this position. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Must be willing to work flexible hours. Ability to work weekends and off-shift hours, as needed to support manufacturing activities. Lifting up to 25 pounds on occasion. Ability to wear restrictive gowning for extended periods of time during periods of prolonged standing. Attendance is mandatory.