Analyst 1, QC Compendial Testing

Fujifilm • Holly Springs, NC

2d • Onsite

About The Position

The Analyst 1, QC Compendial Testing ensures laboratory operations are good manufacturing practices (GMP)-compliant according to United States\Europe\Japan pharmacopeia (USP/EP/JP) regulations. The role participates in the Technology Transfer (TT) of established methods into the FUJIFILM Biotechnologies, North Carolina Quality Control Laboratory. Following TT activities, the position performs material testing and disposition using the established analytical methods. 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.”

Requirements

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry or related scientific discipline with 0-1 years of applicable industry experience.
• Basic understanding of GMP, GLP, GDP requirements.
• Computer proficiency.
• Effective problem-solving skills.
• Results-oriented and strong interpersonal skills.
• Ability to work in a fast-paced environment.
• Excellent attention to detail.
• Excellent verbal and written communication skills.
• Ability to complete tasks independently and with guidance/supervision.
• Self-driven, flexible and champions a collaborative attitude for the team.

Nice To Haves

• Master’s degree in Biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 0+ years of experience.
• 1-3 years relevant experience.
• Familiar with compendial testing methodology as it pertains to cGMP.
• Experience in assay troubleshooting and problem solving.
• Experience in a GMP environment.

Responsibilities

• Supports material life cycle management (new material assessment, specification establishment, maintenance of specifications etc.) under supervision.
• Supports QC Compendial Testing team on internal TT meetings related to new products.
• Assists the QC Manager in the implementation of new technologies.
• Authors and reviews procedures, protocols, reports and specifications related to compendial testing of materials under supervision and support.
• Performs testing and disposition of incoming raw materials and components according to specifications and procedures; adheres to predefined turnaround times.
• Executes actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs.
• Initiates and implements TrackWise deviations and invalid assays, corrective and preventative actions (CAPAs); executes lab exceptions.
• Performs routine investigations in support of Out-of-Specification testing results.
• Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results.
• Follows established policies and procedures and escalates to management areas where enhancements will improve daily work.
• Reviews new and updated specifications.
• Utilizes Material Safety Data Sheets to properly assess chemical hazards, spill response procedures, and personal protective equipment (PPE) requirements, if indicated.
• Performs other duties, as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level