Quality Assurance Specialist II, Supplier Quality
3 weeks ago
Job Summary
The Quality Assurance Specialist II, Supplier Quality will be responsible for supporting the supplier quality program. This role will assist with ensuring all suppliers of raw materials, consumables, and GMP services are qualified prior to use within the facility.
Key Responsibilities
- Compliance: Represent the company in external audits and inspections, and support the organization in conducting internal audits.
- Quality Assurance: Maintain approved supplier lists, process and track complaints to suppliers, and develop and issue weekly and monthly metric reporting on supplier performance.
- Leadership: Work collaboratively with site management to instill a Quality Culture by coaching in applying GMP Principles.
- New Business Growth: Support client due diligence and Quality audits, as well as regulatory inspections.
Requirements
- 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 work.
- Ability to work independently with little supervision.
- Proficient in Microsoft Excel, Word and PowerPoint.
- Working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
Working Conditions
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. 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 associated with this position. 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 is required. Must be willing to work flexible hours. Ability to work weekends and off-shift hours, as needed to support manufacturing activities. Must be willing to travel occasionally, as needed. Attendance is mandatory.
Qualifications
- Masters degree in a science-related field with 1 year of cGMP experience supporting pharmaceutical or biotechnology products; OR
- Bachelors degree in a science-related field with 2 years of cGMP experience supporting pharmaceutical or biotechnology products; OR
- Associates degree with 4 years of cGMP experience supporting pharmaceutical or biotechnology products.
About FUJIFILM Corporation
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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