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QA Specialist, Drug Product

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 22 August 2026 (23 days ago)

Application Deadline: 19 November 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

The QA Specialist Drug Product (DP) helps drive the Quality oversight for the direction of all DP Manufacturing processes through to operational readiness during project phase. This role oversees QAs day-to-day activities and resolution or mitigation of issues.

Company Overview

FUJIFILM 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

Supports the development of documents processes and procedures for the Drug Product program.
Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing systems are maintained in a validated state from startup into commercial operation.
Provides oversight and approval of system and process lifecycle documentation including risk and impact assessments product and process equipment specifications functional specifications traceability matrices qualification protocols validation plans and validation summary reports.
Generates reviews and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems.
Generates reviews and approves QA documentation procedures and processes for operational readiness objectives and QA support of manufacturing operations in a current Good Manufacturing Practice (cGMP) regulated facility.
Ensures the fulfillment of project and operational quality objectives within desired timelines.
Provides Manufacturing shop floor support including Acceptable Quality Limit (AQL) critical process step verification issue
resolution line clearance and alarm response.
Participates in optimization or improvement initiatives; supports regulatory agency and third-party inspections.
Performs other duties as assigned.

Knowledge Skills or Abilities

Excellent verbal and written communication skills to partner with different teams and stakeholders; fluency in English.
Strong time management; ability to meet tight deadlines to ensure effective prioritization of tasks.
Critical thinking and superior problem-solving skills.
Collaborative attitude; willingness to work with global peers and cross-functional teams toward company and department goals.
Basic knowledge and application of cGMP compliance and other related regulations.
Ability to fully embrace a Genki culture and bring positive energy to a dynamic work environment.
Flexible to support a 24/7 manufacturing facility.
The position also has occasional opportunities for international and/or domestic travel.

Minimum Requirements:

Bachelors degree in Life Sciences Engineering or equivalent with 2 years of applicable industry experience; OR
Masters degree in Life Sciences or Engineering with 0 years of applicable experience.
1 years of experience working in a GMP regulated environment.
Experience in Validation cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility.

Preferred Requirements:

High level understanding/familiarity of validation of production equipment hygienic utilities quality systems automation methodologies manufacturing and IT Systems.
Understanding of GAMP5 Data Integrity and application of 21 CFR Part 820 and Part 11.
Understanding of formulation aseptic filling and/or visual inspection.
Working knowledge and experience with ASTM E2500 Smartsheet Trackwise Veeva Kneat validation software and/or PAS-X.
Experience with startup Projects or initiatives.

Working Conditions & Physical 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 120 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.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions.
Will work in warm/cold environment 2-8 degrees C.

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:

IC

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About Company

Fujifilm

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