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Quality Assurance Specialist II, Supplier Quality
4 weeks ago
About the Role:
The Quality Assurance (QA) Compliance Analyst 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: Ensure all suppliers meet regulatory requirements and company standards.
- QA Representative: Interface with external suppliers to ensure quality and compliance.
- Internal Audits: Support the organization in conducting internal audits and hosting audits/inspections.
- Supplier Management: Maintain approved supplier list, process/track complaints, and develop 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:
- Master's degree in a science-related field with 1 year of cGMP experience supporting pharmaceutical or biotechnology products; OR
- Bachelor's 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.
Preferred Qualifications:
- Degree in Biology, Chemistry or Engineering
- Six Sigma Green/Black Belt cGMP experience.
- ASQ Quality Auditor Certification
- cGMP experience
About FUJIFILM Diosynth Biotechnologies:
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.
