Senior Analyst 1, QC Compendial Testing

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking a Senior Analyst 1, QC Compendial Testing to ensure GMP-compliant testing of materials and support technology transfer into the Quality Control Laboratory.

The role involves collaboration with QA, Supply Chain, Manufacturing and Contract Laboratories to maintain data integrity, support manufacturing timelines, and drive continuous improvement in analytical testing capabilities.

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.

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 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.

Skills

Oral & written communication

English fluency

Analytical skills

Data analysis

Collaboration / teamwork

Attention to detail

Safety procedures knowledge

Adaptability (24/7)

Education

Bachelor's degree in Chemistry/Biology/Biochemistry/Microbiology

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

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.