Analyst 1, QC Compendial Testing

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 52,000 - 68,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina is seeking an Analyst 1, QC Compendial Testing to ensure GMP-compliant operations and support the tech transfer of approved methods into the NC Quality Control Laboratory.

The role involves testing and disposition of incoming materials, collaborating with TT teams, and assisting in the implementation of new technologies while maintaining rigorous QA documentation and lab systems.

Qualifications

• 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.

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.
• 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 PPE requirements, if indicated.
• Performs other duties, as assigned.

Skills

Computer proficiency

Problem solving

Interpersonal skills

Fast-paced environment

Attention to detail

Communication skills

Independent work

Team collaboration

Education

Bachelor's degree in Chemistry/Biology/Biochemistry

Master’s degree in Biology/Chemistry/Biochemistry/Microbiology

Job description

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.

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.

Minimum Qualifications

• 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 Qualifications

• 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.