Lead QC Specialist: HPLC & Methods Expert

FUJIFILM Holdings America Corporation; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Paid time off

Health Savings Account

Job summary

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

You will serve as SME for CAPAs, deviations, investigations, method revisions, and data reviews, leading problem solving and continuous improvement through lean lab and Six Sigma principles.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with at least 2 years of direct experience.
• Strong experience with HPLC.

Responsibilities

• Lead laboratory support functions and procedures within the assigned discipline.
• Serve as SME for CAPAs, deviations, investigations, method revisions, and data reviews.
• Lead problem solving and recommendations for mitigation and improvement.
• Coordinate lab testing, data review, and documentation.
• Lead/SME for method transfers, validations, and qualifications.
• Apply lean lab and Six Sigma principles to processes.

Skills

HPLC

Education

Bachelor's degree in Chemistry/Biochemistry/Pharmaceutical Sciences

Tools

Trackwise

Deviation writing

Job description

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

You will serve as SME for CAPAs, deviations, investigations, method revisions, and data reviews, leading problem solving and continuous improvement through lean lab and Six Sigma principles.