Analyst 1, QC Compendial Testing

Fujifilm•Holly Springs, NC

23d•Onsite

About The Position

The Analyst 1, QC Compendial Testing ensures laboratory operations comply with good manufacturing practices (GMP) and United States, European, and Japanese pharmacopeia (USP/EP/JP) regulations. The role participates in transferring established methods into FUJIFILM Biotechnologies’ North Carolina Quality Control Laboratory and, after transfer activities, performs material testing and disposition using those methods. The position supports material life cycle management and the QC Compendial Testing team’s technology-transfer activities for new products. It performs testing and disposition of incoming raw materials and components, supports laboratory systems and investigations, and authors or reviews compendial testing documentation under supervision and support. FUJIFILM Biotechnologies is developing a biopharmaceutical manufacturing facility in Holly Springs, North Carolina, with drug substance production, fill-finish, and packaging. The company describes its culture as “Genki” and its Group Purpose as “giving our world more smiles.”

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 and flexible, with a collaborative attitude.
Ability to discern audible cues.
Ability to inspect or perform tasks with 20/20 corrected vision and visual acuity, including distinguishing color.
Ability to stand for prolonged periods, up to 240 minutes.
Ability to sit for prolonged periods, up to 240 minutes.
Ability to perform repetitive motions involving wrists, hands, and/or fingers.
Ability to move objects up to 10 pounds.
Ability to bend, push or pull, reach to retrieve materials from 18 to 60 inches in height, and use twisting motions.

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 life cycle management, including new material assessment and the establishment and maintenance of specifications, under supervision.
Support internal technology-transfer meetings related to new products for the QC Compendial Testing team.
Assist the QC Manager with implementation of 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, adhering to predefined turnaround times.
Execute actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs.
Initiate and implement TrackWise deviations and invalid assays, corrective and preventative actions (CAPAs), and execute lab exceptions.
Perform routine investigations in support of out-of-specification testing results.
Support maintenance of effective laboratory systems to ensure 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.