Senior Analyst 1, QC Compendial Testing

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 75,000 - 90,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking a Senior Analyst 1, QC Compendial Testing to ensure GMP-compliant laboratory operations under USP/EP/JP regulations. This role supports technology transfer of methods into QC lab and conducts material testing and disposition using established analytical methods.

The position requires a strong background in compendial testing, cGMP experience, and collaboration with QA, manufacturing, and supply chain teams.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry or related field with 2+ years of industry experience.
• Master’s degree in a relevant science with no prior experience.
• Experience with compendial testing methodology per cGMP.

Responsibilities

• Supports material life cycle management (new material assessment, specification establishment, maintenance of specifications, etc.).
• Authors and reviews procedures, protocols, reports and specifications related to raw materials and materials requiring compendial testing.
• Performs routine and non-routine testing of incoming materials and components following compendial (USP/EP/JP) and internal methods.
• Assesses and executes actions related to change controls and vendor change notifications.
• Initiates and implements TrackWise deviations, corrective and preventive actions (CAPAs), lab exceptions and invalid assays.
• Ensures adherence to company quality policies, SOPs and industry regulations while maintaining laboratory integrity.
• Assists in implementing new technologies and collaborates cross-functionally with QA, Supply Chain, Manufacturing and contract labs.
• Performs routine investigations in support of Out-of-Specification testing results.
• Provides technical guidance and training to junior analysts.

Skills

Analytical testing

Data interpretation

Quality systems

Cross-functional collaboration

Scientific writing

English fluency

Education

Bachelor’s in Chemistry/Biology/biochemistry

Master’s in relevant science

Tools

LIMS TrackWise

MS Office

Job description

The Senior Analyst 1, QC Compendial Testing ensures laboratory operations are Good Manufacturing Practices (GMP)-compliant according to United States/Europe/Japan (USP/EP/JP) regulations. The role participates in the Technology Transfer (TT) of established methods into the Quality Control Laboratory as well as 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.).
• Authors and reviews procedures, protocols, reports and specifications related to raw materials and materials requiring compendial testing.
• Performs routine and non-routine testing of incoming materials and components following compendial (USP/EP/JP) and internal methods.
• Assesses and executes actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs.
• Initiates and implements Trackwise deviations, corrective and preventive actions (CAPAs), lab exceptions and invalid assays.
• Ensures adherence to company quality policies, SOPs and industry regulations while supporting maintenance of effective laboratory systems, ensuring integrity of all laboratory results, and a safe and organized laboratory environment.
• Assists in the implementation of new technologies.
• Collaborates cross-functionally with Quality Assurance, Supply Chain, Manufacturing and Contract Laboratory teams to resolve quality related issues and support manufacturing timelines.
• Performs routine investigations in support of Out-of-Specification testing results.
• Provides technical guidance and training to junior analysts and supports continuous improvement initiatives.
• Utilizes Safety data sheets (SDS’s) 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

• Excellent oral and written communications skills and fluency in English.
• Computer proficiency; excellent analytical skills; ability to analyze raw data, assess assay and system suitability criteria.
• Ability to build relationships, maintain a team-based attitude, collaborate/partner with different teams and stakeholders as well as work independently.
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Excellent attention to detail and organization; capability to absorb and utilize new knowledge in a fast-paced environment.
• Flexible to support a 24/7 manufacturing facility.

Minimum Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline with 2+ years of applicable industry experience; OR,
• Master’s degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline with no previous experience.
• Experience with compendial testing methodology as it pertains to cGMP.

Preferred Qualifications

• Master’s degree in Biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 1+ years of experience.
• 1+ years of experience in a GMP environment.
• Experience in assay troubleshooting and problem solving.