Analyst 1, QC Compendial Testing

About the Role

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.

What You'll Do

• 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

Qualifications

Minimum:

• 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

Preferred:

• 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

Knowledge, Skills, and Abilities

• 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

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
• Will work in warm/cold environments
• Will work in small and/or enclosed spaces