Lead QC Associate II, Raw Materials - Bioprocess Lab

FUJIFILM Biotechnologies; Milwaukee (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid vacation

Job summary

FUJIFILM Biotechnologies is seeking a Lead QC Associate II – Raw Materials at our Bioprocess Innovation Center in Morrisville, NC. You will oversee sampling, testing, and releasing incoming raw materials to ensure GMP and USP/EP/JP compliance and data integrity.

You will act as SME for method transfers, validations and deviations, drive continuous improvement, and support documentation and CAPA activities within the Quality Control laboratory.

Qualifications

• BS/BA in science with at least 2 years of direct experience.

Responsibilities

• Sampling, testing, and release of incoming raw materials.
• Lead investigations, CAPAs, deviations, and quality system activities.
• Provide technical writing and data interpretation for reports.
• Lead method transfers, validations and qualifications.
• Support data integrity and continuous improvement in QC.

Skills

GMP compliance

Problem solving

Data review

Technical writing

Method transfer

Education

BS/BA in science

Tools

FTIR

RAMAN

Karl Fischer

Polarimeter

Refractometer

Job description

FUJIFILM Biotechnologies is seeking a Lead QC Associate II – Raw Materials at our Bioprocess Innovation Center in Morrisville, NC. You will oversee sampling, testing, and releasing incoming raw materials to ensure GMP and USP/EP/JP compliance and data integrity.

You will act as SME for method transfers, validations and deviations, drive continuous improvement, and support documentation and CAPA activities within the Quality Control laboratory.