Lead QC Specialist II — HPLC & Method Validation

FUJIFILM Biotechnologies; Milwaukee (WI); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with company contributions

Paid vacation and holidays

Job summary

FUJIFILM Biotechnologies seeks a Lead QC Associate II to support a broad range of analytical disciplines within the Quality Control laboratory, delivering high-throughput, right-first-time results to meet production schedules. The role requires minimal supervision and strong expertise in chromatography and related QC practices.

The incumbent will act as SME for CAPAs, deviations, investigations, and method transfers/validations, applying lean lab and six sigma principles to improve processes and

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

• Responsible for a broad range of laboratory support functions and procedures as assigned, demonstrating expertise in technical skills, disciplines, and procedures within assigned discipline area(s).
• Demonstrated subject matter expert and responsible for CAPA’s, audit actions, deviations, lab investigations, method revisions, and other relayed Quality System activities.
• Takes lead in problem solving and troubleshooting, makes recommendations for mitigation and improvement.
• Lead/SME for method transfers, method validations and method qualification.
• Reviews technical data and provides expert review and input to new methods and revisions. Creates data reviews, summary reports, and provides expert interpretation of data.

Skills

HPLC

Education

Bachelor's degree in Chemistry/ Biochemistry/ Pharmaceutical Sciences

Tools

Trackwise

FTIR

RAMAN

Karl Fischer

Polarimeter

Refractometer

Job description

FUJIFILM Biotechnologies seeks a Lead QC Associate II to support a broad range of analytical disciplines within the Quality Control laboratory, delivering high-throughput, right-first-time results to meet production schedules. The role requires minimal supervision and strong expertise in chromatography and related QC practices.

The incumbent will act as SME for CAPAs, deviations, investigations, and method transfers/validations, applying lean lab and six sigma principles to improve processes and