Senior Analyst 1, QC Compendial Testing

FUJIFILM Healthcare Americas Corporation; Holly Springs (NC); On-site; USD 65,000 - 95,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior Analyst 1 for QC Compendial Testing to ensure GMP-compliant operations per USP/EP/JP standards. You will participate in technology transfer of analytical methods into QC labs and perform material testing with established methods.

The role collaborates with QA, supply chain, and manufacturing to resolve quality issues and support timelines, with growth opportunities in technology implementation.

Qualifications

• Excellent oral and written communication in English required.
• Strong analytical skills with data interpretation.
• Ability to work cross-functionally with QA, Supply Chain, Manufacturing and Contract Labs.
• Familiarity with compendial testing methods (USP/EP/JP) and cGMP.

Responsibilities

• Supports material lifecycle management including new material assessment and specification maintenance.
• Authors and reviews procedures, protocols, reports and specifications for materials requiring compendial testing.
• Performs routine and non-routine testing of incoming materials per compendial methods and internal SOPs.
• Handles change controls and vendor change notifications; initiates CAPAs and lab deviations.
• Ensures adherence to quality policies, SOPs, and maintains integrity of lab results and safety.

Skills

Communication skills

Fluency in English

Analytical skills

Team collaboration

Safety procedures

Education

Bachelor's degree in Chemistry/ Biology / Microbiology / Biochemistry

Master's degree in Chemistry/ Biology / Biochemistry or related field

Tools

Trackwise

Job description

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, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re 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 we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll 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.
• Assess 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 (SDS’s) 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

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline with 2+ years of applicable industry experience; OR,
• Master’s 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

• Master’s 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 committed to 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 ([e-mail]).