QA Materials & Compliance Specialist II

FUJIFILM Biotechnologies; Milwaukee (WI); Hybrid; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) plan with company match

Paid vacation and holidays

Job summary

FUJIFILM Biotechnologies seeks a QA Technical Specialist II to finalize disposition of GMP raw materials and consumables, ensuring timely production input. You will coordinate with Warehouse, Supply Chain, and QC Raw Materials to resolve material issues and escalate as needed.

The role performs quality impact assessments for investigations, change controls, and supplier change notifications, and ensures data integrity per 21 CFR Part 820/Part 11. Cross‑functional teamwork is essential.

Qualifications

• High School Diploma or equivalent with 9+ years applicable industry experience; OR
• Associate’s degree with 7+ years; OR
• Bachelor’s degree with 5+ years; OR
• Master’s degree with 3+ years.
• Hands‑on experience with SAP (material status/transactions) and Microsoft Office.
• Experience working within GMP quality systems (deviations, change control, investigations).
• Strong written and verbal communication, organization, critical thinking, and attention to detail.
• Demonstrated ability to multitask, prioritize, and meet timelines in a GMP environment.

Responsibilities

• Execute QA disposition of GMP raw materials and consumables to support manufacturing schedules.
• Update and manage material status and associated records in SAP.
• Contribute to and review quality system records (e.g., deviations, change management, change controls) in TrackWise.
• Perform quality impact assessments for investigations and supplier change notifications related to raw materials/consumables.
• Collaborate with Warehouse, Supply Chain, QC Raw Materials, and Quality leadership to resolve issues, drive timely decisions, and maintain flow of materials.
• Review and adhere to applicable SOPs and work instructions; identify and support procedural improvements.
• Uphold data integrity and ensure compliance with 21 CFR Part 820 and Part 11, and internal quality standards.

Skills

Quality systems

Cross‑functional work

Data integrity

Problem solving

multitask & deadline oriented

Education

Bachelor's degree with 5+ years

Master’s degree with 3+ years

Associate’s degree with 7+ years

High School Diploma with 9+ years

Tools

SAP

Microsoft Office

TrackWise

Job description

FUJIFILM Biotechnologies seeks a QA Technical Specialist II to finalize disposition of GMP raw materials and consumables, ensuring timely production input. You will coordinate with Warehouse, Supply Chain, and QC Raw Materials to resolve material issues and escalate as needed.

The role performs quality impact assessments for investigations, change controls, and supplier change notifications, and ensures data integrity per 21 CFR Part 820/Part 11. Cross‑functional teamwork is essential.