Senior Analyst 1, QC Compendial Testing

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, 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.
• 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 (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 m