Manager, QC Microbiology

Fujifilm

Posted on : 13-06-2025

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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 : 13-06-2025

Job Description

Position Overview

The Manager QC Microbiology is responsible for contributing to key functional tactical and operational aspects of the QC group at Fujifilm
Biotechnologies. Project management initiation of process improvements liaison for qualification and validation activities modeling the leadership competencies aiding in the development of peers and performing QC approval as required. The Manager QC Microbiology is proficient in their understanding of Quality Systems and applies that knowledge in leading projects coaching and continuous improvements of systems cross-functionally.

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

Accountable for GMP compliant laboratory operations according to EU GMP and 21 CFR partand other applicable GMP guidelines
Mentors teams cross-functionally as a representative of the QC Microbiology laboratory
Coordinates the review of analytical data to support test validation qualification and certification activities. Performs investigations manages complex issues barriers and problems to support team success. Approve data reports within the team and area of discipline/focus including approval of results
Authors protocols change control requests and Quality Technical Reports for ensuring successful execution of qualification analytical
improvement projects in collaboration with cross-functional teams as appropriate
Provides technical leadership through effective project management status tracking presentations and communication
Proactively identifies technical gaps and areas for improvement related to quality. Process and lead internal and external audits proficiently including commitments on follow up
Within team & site management serves as External Leadership for the project
Represents QC interdepartmentally on QC projects with limited support for efficient and collaborative interaction with internal and external stakeholders
Routinely provides direction to subordinates. Ensure team motivation through initiatives to ensure a positive working environment and values team over individual success. Mentors junior members of the team in quality systems process improvements
Set requirements; deliverables and measurable goals & targets mitigation plans which are aligned to quality directive regulatory guidance business imperatives
Ensures issues/deviations are mitigated appropriately
Manages complex problem solving providing mitigation/outcome to management/team. Decisions at this level include those that have potential compliance impact to methods results product and/or Quality systems decisions with impact to customers or pertaining to personnel issues that must be handled with consultation and recommendations to management. Supports key business strategies
Conducts approval of complex reports data of others; Leads complex problem solving through facilitation/escalation. Conducts impact assessment related to compliance (e.g.; global directives audit finding/readiness deviations).
Provides technical support during audits/inspections
Ensures adherence to all regulatory licenses and regulations serving as a subject matter expert in multiple disciplines interfacing with key customers
Completes required administrative tasks (e.g. timecard approvals time off approvals expense reports etc.)
Coaches and guides direct reports to foster professional development
Participates in the recruitment process and retention strategies to attract and retain talent as needed
Addresses performance gaps employee questions and concerns and partners with HR as needed for resolution
Performs other duties as assigned

Minimum Requirements:

Bachelors degree in Chemistry Microbiology Biological Sciences Engineering or related science with 7 years of experience OR
Masters degree in Chemistry Microbiology Biological Sciences Engineering or related science with 5 years of experience OR
Ph.D. in Chemistry Microbiology Biological Sciences Engineering or related science with 3 years of experience
2-5 years of people management experience
Experience working in a regulated GMP environment

Preferred Requirements:

5 years of experience in a GMP environment

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color.

Ability to stand for prolonged periods of time up to 240 minutes.

Ability to sit for prolonged periods of time up to 240 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.

Will work in warm/cold environments.

Will work in heights greater than 4 feet.

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:

Manager

Employment Type

Unclear

Company Industry

Department / Functional Area

Quality Control

Key Skills

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About Company

Fujifilm

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Manager, QC Microbiology

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Department / Functional Area

Key Skills

About Company

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