Analyst 1, QC Compendial Testing

Fujifilm•Holly Springs, NC

24d

About The Position

The Analyst 1, QC Compendial Testing supports GMP-compliant laboratory operations in accordance with USP, EP, and JP requirements. The position participates in transferring established methods into FUJIFILM Biotechnologies’ North Carolina Quality Control Laboratory and, following technology transfer, performs testing and disposition of materials using the established analytical methods. The role supports material lifecycle management, including new material assessment and specification establishment and maintenance. It also contributes to internal technology transfer meetings for new products, implementation of new technologies, documentation, change controls, investigations, and the maintenance of effective laboratory systems. Work is performed under supervision and support where indicated. The position is based in Holly Springs, North Carolina. Physical demands include prolonged standing or sitting, repetitive hand and wrist motions, handling objects up to 10 pounds, bending, pushing or pulling, reaching, and working in warm or cold environments and small or enclosed spaces.

Requirements

Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry, or a related scientific discipline.
0–1 years of applicable industry experience.
Basic understanding of GMP, GLP, and GDP requirements.
Computer proficiency.
Effective problem-solving skills.
Results-oriented approach 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 or supervision.
Self-driven, flexible, and collaborative attitude.

Nice To Haves

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

Responsibilities

Support material lifecycle management, including new material assessment and specification establishment and maintenance, under supervision.
Support QC Compendial Testing team internal technology transfer meetings related to new products.
Assist the QC Manager with implementing new technologies.
Author and review procedures, protocols, reports, and specifications related to compendial testing of materials, with supervision and support.
Test and disposition incoming raw materials and components according to specifications and procedures, meeting predefined turnaround times.
Execute actions related to change controls and vendor change notifications from partners or arising from internal or compendial needs.
Initiate and implement TrackWise deviations, invalid assays, and corrective and preventative actions (CAPAs), and execute laboratory exceptions.
Perform routine investigations supporting out-of-specification test results.
Support maintenance of effective laboratory systems to ensure the integrity of laboratory results.
Follow established policies and procedures and escalate opportunities to improve daily work.
Review new and updated specifications.
Use Material Safety Data Sheets to assess chemical hazards, spill response procedures, and personal protective equipment requirements when indicated.
Perform other duties as assigned.