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Senior Analyst 1, QC Compendial Testing

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 22 August 2026 (11 hours ago)

Application Deadline: 19 November 2026

Vacancies: 1 Vacancy

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Department:

Quality Control

Job Summary

Position Overview

The Senior Analyst 1 QC Compendial Testing ensures laboratory operations are Good Manufacturing Practices (GMP)-compliant according to United States/Europe/Japan (USP/EP/JP) regulations. The role participates in the Technology Transfer (TT) of established methods into the Quality Control Laboratory as well as performs material testing and disposition using the established analytical methods.

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 material life cycle management (new material assessment specification establishment maintenance of specifications etc.).
Authors and reviews procedures protocols reports and specifications related to raw materials and materials requiring compendial testing.
Performs routine and non-routine testing of incoming materials and components following compendial (USP/EP/JP) and internal methods.
Assesses and executes actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs.
Initiates and implements Trackwise deviations corrective and preventive actions (CAPAs) lab exceptions and invalid assays.
Ensures adherence to company quality policies SOPs and industry regulations while supporting maintenance of effective laboratory systems ensuring integrity of all laboratory results and a safe and organized laboratory environment.
Assists in the implementation of new technologies.
Collaborates cross-functionally with Quality Assurance Supply Chain Manufacturing and Contract Laboratory teams to resolve quality related issues and support manufacturing timelines.
Performs routine investigations in support of Out-of-Specification testing results.
Provides technical guidance and training to junior analysts and supports continuous improvement initiatives.
Utilizes Safety data sheets (SDSs) to properly assess chemical hazards spill response procedures and personal protective equipment (PPE) requirements if indicated.
Performs other duties as assigned.

Knowledge Skills and Abilities

Excellent oral and written communications skills and fluency in English.
Computer proficiency; excellent analytical skills; ability to analyze raw data assess assay and system suitability criteria.
Ability to build relationships maintain a team-based attitude collaborate/partner with different teams and stakeholders as well as work independently.
Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
Excellent attention to detail and organization; capability to absorb and utilize new knowledge in a fast-paced environment.
Flexible to support a 24/7 manufacturing facility.

Minimum Qualifications

Bachelors degree in Chemistry Biology Microbiology Biochemistry or other relevant scientific discipline with 2 years of applicable industry experience; OR
Masters degree in Chemistry Biology Microbiology Biochemistry or other relevant scientific discipline with no previous experience.
Experience with compendial testing methodology as it pertains to cGMP.

Preferred Qualifications

Masters degree in Biology Chemistry Biochemistry Microbiology or other relevant scientific discipline with 1 years of experience.
1 years of experience in a GMP environment.
Experience in assay troubleshooting and problem solving.
Experience with Trackwise.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job the employee is required on a regular basis to:

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 for up to 240 minutes.
Ability to sit for prolonged periods of time for up to 240 minutes.
Ability to conduct activities using repetitive motions that include wrists 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 environments.
Will work in small and/or enclosed spaces.

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

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About Company

Fujifilm

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