Analyst 1, QC Compendial Testing

About the role

The 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 FUJIFILM Biotechnologies, North Carolina Quality Control Laboratory.

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.
• Sustains 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.

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.

Qualifications

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

Physical Requirements

• Ability to discern audible cues.
• 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.