Lead QC Associate II - HPLC & Method Expert

FUJIFILM Holdings America Corporation; North Carolina; On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) savings plan

Health Savings Account with company

Job summary

FUJIFILM Biotechnologies in North Carolina is seeking a Lead QC Associate II to support a broad range of analytical disciplines in the Quality Control laboratory. The role emphasizes high throughput, right-first-time testing to meet production schedules and project milestones with minimal supervision.

The position requires a BS/BA in a related science and strong HPLC experience; preferred familiarity with Trackwise, FTIR, RAMAN, Karl Fischer, and other analytical tools.

Qualifications

• Bachelor of Science or Bachelor of Arts - preferably in Chemistry, Biochemistry, Pharmaceutical Sciences, or related technical field with at least 2 years of direct experience.
• Strong experience with HPLC.

Responsibilities

• Lead laboratory support functions and procedures within the assigned discipline, showing expertise in technical skills and procedures.
• Manage CAPAs, audit actions, deviations, lab investigations, and method revisions within the Quality System.
• Lead problem solving, mitigation, and continuous improvement initiatives.
• Support all laboratory and assay functions including housekeeping, safety, equipment use and data review.
• Lead/SME for method transfers, method validations and method qualification.
• Apply lean lab and six sigma principles to laboratory processes.
• Review data and provide expert interpretation, develop data reviews and summary reports.
• Notify management of deviations and initiate events in quality systems.
• Prioritize work to meet schedules; coordinate logistics for testing and documentation.
• Prepare technical writing such as reports and deviations from templates.

Skills

HPLC

Education

BS in Chemistry / Biochemistry / Pharmaceutical Sciences or related field

Tools

Trackwise

FTIR

RAMAN

Karl Fischer

Polarimeter

Refractometer

Job description

FUJIFILM Biotechnologies in North Carolina is seeking a Lead QC Associate II to support a broad range of analytical disciplines in the Quality Control laboratory. The role emphasizes high throughput, right-first-time testing to meet production schedules and project milestones with minimal supervision.

The position requires a BS/BA in a related science and strong HPLC experience; preferred familiarity with Trackwise, FTIR, RAMAN, Karl Fischer, and other analytical tools.