Lead QC Specialist II — HPLC & Method Validation Lead

FUJIFILM Electronic Materials (Europe) N.V.; North Carolina; On-site; USD 85,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina seeks a Lead QC Associate II to support a broad range of analytical disciplines in a Quality Control lab. You will perform high-throughput, right-first-time work with minimal supervision, focusing on chromatographic analyses and data review.

The role requires 2+ years in QC with strong HPLC experience, CAPA ownership, and the ability to lead method transfers, validations, and investigations in a fast-paced biotech environment.

Qualifications

• Bachelor of Science or Bachelor of Arts in chemistry, biochemistry, pharmaceutical sciences, or related technical field with at least 2 years of direct experience.
• Strong experience with HPLC.

Responsibilities

• Provide broad QC support across analytical operations, ensuring right-first-time results.
• Lead CAPA efforts, deviations, audits, investigations, method revisions, and quality system activities.
• Drive problem solving and implement corrective actions to improve processes.
• Support lab housekeeping, safety, equipment maintenance, logbooks, data review and documentation.
• Lead/SME for method transfers, validations and qualifications.
• Apply lean lab and six sigma principles to laboratory processes.
• Review data, prepare reports, and provide expert interpretation of results.
• Communicate deviations and events to management and initiate quality system entries.
• Coordinate testing logistics and documentation with team members.
• Contribute to project work, writing and review of procedures and deviations.
• Mentor teammates and support cross-functional collaboration.

Skills

HPLC

Education

Bachelor in Chemistry / Biochemistry / Pharmaceutical Sciences

Tools

Trackwise

FTIR

RAMAN

Karl Fischer

Polarimeter

Refractometer

Job description

FUJIFILM Biotechnologies in North Carolina seeks a Lead QC Associate II to support a broad range of analytical disciplines in a Quality Control lab. You will perform high-throughput, right-first-time work with minimal supervision, focusing on chromatographic analyses and data review.

The role requires 2+ years in QC with strong HPLC experience, CAPA ownership, and the ability to lead method transfers, validations, and investigations in a fast-paced biotech environment.