Senior Analyst 1, QC Compendial Testing

About the role

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

Responsibilities

• 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
• Affirms 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
• Aids 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

Requirements

• 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

• 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
• Works in warm/cold environments
• Works in small and/or enclosed spaces

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

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!