Senior Quality Engineer, Supplier Management
6 days ago
The Senior Quality Engineer, Supplier Management, plays a critical role in ensuring that suppliers of services or materials to Fujifilm Diosynth Biotechnologies meet the highest quality standards while conforming to pre-established requirements, including cGMPs.
Key Responsibilities- Prepare, conduct, and report results of audits of GMP service providers and suppliers of various GMP materials, and internal processes to meet quality compliance requirements.
- Create and maintain a list of approved suppliers/service providers.
- Establish and maintain policies, procedures, checklists, self-assessment surveys, and additional forms for the internal and supplier audit programs.
- Monitor raw material supplier quality and work directly with Supply Chain, QA, and suppliers to improve performance.
- Oversee and report on the progress of audit corrective and preventative actions and audit findings for both the internal and supplier audit programs during Quality Management Meetings.
- Support Quality management contact with regulatory authorities worldwide as well as partners regarding quality issues, including field alerts, recalls, or regulatory actions.
- Support GMP inspections and audits from regulatory authorities and partners and support drafting of follow-up responses for all aspects of the business.
- Support other GXP functions, as required.
- Support and participate in the supplier change notification and supplier complaints.
- Perform other duties, as assigned.
- Bachelor's Degree in Life Sciences or Engineering with 9+ years of applicable cGMP experience OR
- Masters in Life Sciences or Engineering and 7+ years of applicable cGMP experience OR
- PhD in Life Sciences or Engineering and 5+ years of applicable cGMP experience
- 5+ years' experience in a cGMP Quality, in an FDA regulated facility
- Prior Experience and Knowledge of pharmaceutical industry and regulations
- Proficient in MS Office suite
- Previous experience of Smartsheet, Track wise, Master Control, Veeva and/or Kneat validation software.
- Occasional opportunity for International and/or Domestic travel may be available.
- Experience conducting internal audits.
- Certified ISO 9001 Auditor Training
- ASQ - Certified Quality Auditor
Fujifilm Diosynth Biotechnologies is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.
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