Senior Analyst 1, QC Raw Materials

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading biotechnology firm in North Carolina is seeking a Senior Analyst 1 for their Quality Control department. The role involves overseeing GMP compliant laboratory operations and participating in technology transfer activities. Candidates should have a Bachelor's degree in a relevant scientific discipline, with 1-3 years of experience in a GMP environment. Responsibilities include testing and disposition of raw materials, technical writing, and ensuring compliance with specifications. The position offers opportunities for professional growth in a dynamic lab setting.

Qualifications

• 1-3 years relevant experience in a GMP environment.
• Computer proficiency required.
• Familiarity with Raw Material methodology and assay troubleshooting.

Responsibilities

• Support raw material life cycle management and internal tech transfer.
• Perform testing and disposition of incoming raw materials.
• Assist in the implementation of new technologies and enforce policies.

Skills

Assessment of raw materials

GMP compliance

Technical writing

Laboratory investigations

Assay troubleshooting

Education

Bachelor's Degree in Chemistry, Biology, Microbiology, or Biochemistry

Master's Degree in relevant scientific discipline

Job description

The Senior Analyst 1, QC Raw Materials is accountable for GMP compliant laboratory operations according to USP/EP/JP regulations. The role will be responsible for participating in the Technology Transfer of established methods into the FUJIFILM Biotechnologies, North Carolina Quality Control Laboratory. Following Tech Transfer Activities, the position will be responsible for performing raw material testing and disposition using the established analytical methods.

What You’ll Do

• Under supervision, support raw material life cycle management (new material assessment, specification establishment, maintenance of specifications, etc.).
• Supports QC Raw Materials team on internal tech transfer meetings related to new products.
• Under supervision and support, authors and reviews procedures, protocols, reports and specifications related to the raw material area.
• Performs testing and disposition of incoming raw materials and components according to specifications and procedures.
• Assesses and executes actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs.
• Responsible for initiation and execution of Trackwise deviations, CAPA's, lab exceptions and invalid assays.
• Authors and implements corrective and preventative actions from approved deviations, CAPA's, lab exceptions and invalid assays in Trackwise.
• Performs routine investigations in support of out of specification testing results.
• Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results.
• Enforces established policies and procedures and escalates to management areas where enhancements will improve daily work.
• Assists Manager, QC in the implementation of new technologies.
• Adheres to pre‐defined turnaround times of raw material testing.
• Reviews new and updated specifications.
• Assesses lab exceptions and performs routine investigations.
• Utilizes MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
• Performs other duties, as assigned.

Minimum Qualifications

• Bachelor’s Degree degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline.
• 1‐3 years relevant experience.
• Previous experience in a GMP environment.
• Computer proficiency required.

Preferred Qualifications

• Masters degree in Biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 0+ years’ experience.
• Familiar with Raw Material methodology as it pertains to cGMP,
• Experience in assay troubleshooting and problem solving