QA Sr. Engineer, Supplier Quality

Fujifilm

Posted on : 07-06-2025

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1 Vacancy

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Job Location

Holly Springs, MS - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 07-06-2025

Job Description

Position Overview

The Sr. Engineer Supplier Quality provides supplier oversight to ensure that suppliers of services or materials to Fujifilm Diosynth Biotechnologies are of the highest quality while conforming to pre-established requirements including cGMPs. This role primarily focuses on supplier quality working with suppliers to maintain supplier approvals. This role plays a key role in establishing the Supplier Quality System including but not limited to SOP and Specification development Quality Agreements Risk Assessments Supplier Auditing and Supplier Change Notifications.

Company Overview

FUJIFILM Diosynth Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

What Youll Do

Prepares conducts and reports results of audits of GMP service providers and suppliers of various GMP materials and internal processes to meet quality compliance requirements
Creates and maintains a list of approved suppliers/service providers
Establishes and maintain policies procedures checklists self-assessment surveys and additional forms for the internal and supplier audit programs
Monitors raw material supplier quality and works directly with Supply Chain QA and suppliers to improve performance.
Oversees and reports on the progress of audit corrective and preventative actions and audit findings for both the internal and supplier audit programs during Quality Management Meetings
Supports Quality management contact with the FDA EMA and other regulatory authorities worldwide as well as partners regarding quality issues including field alerts recalls or regulatory actions
Supports GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business
Supports other GXP functions as required
Supports and participates in the supplier change notification and supplier complaints
Performs other duties as assigned

Minimum Requirements:

Bachelors Degree in Life Sciences or Engineering with 8 years of applicable experience OR
Masters in Life Sciences or Engineering and 6 years of applicable experience OR
PhD in Life Sciences or Engineering and 4 years of applicable
4 years of experience working in a GMP regulated environment
Prior Experience and Knowledge of pharmaceutical industry and regulations
Proficient in MS Office suite

Preferred Requirements:

Previous experience of Smartsheet Track wise Master Control Veeva and/or Kneat validation software
Experience conducting internal audits

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to stand for prolonged periods of time up to 30 minutes.

Ability to sit for prolonged periods of time up to 120 minutes.

Ability to conduct activities using repetitive motions that include writs hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Senior IC

Employment Type

Unclear

Company Industry

Key Skills

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About Company

Fujifilm

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QA Sr. Engineer, Supplier Quality

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Key Skills

About Company

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