QA Material Disposition Specialist - GMP & SAP

FUJIFILM Holdings America Corporation; North Carolina; Hybrid; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) plan

Paid time off

Hybrid eligible

Job summary

FUJIFILM Biotechnologies in North Carolina is seeking a QA Technical Specialist II to perform final disposition of GMP raw materials and consumables, ensuring timely availability for manufacturing. You will be the QA point of contact with Warehouse, Supply Chain, and QC RM, handling investigations, change controls, and supplier change notifications.

You will ensure data integrity and compliance with 21 CFR Part 820/Part 11, while collaborating with cross-functional teams to resolve issues and

Qualifications

• 9+ years in pharma/biotech with GMP.
• SAP (material status/transactions) and MS Office experience.
• Experience with GMP quality systems (deviations, change control, investigations).

Responsibilities

• Execute QA disposition of GMP raw materials and consumables.
• Update material status in SAP and manage records.
• Review quality system records (deviations, change controls).
• Perform quality impact assessments for investigations and supplier changes.
• Collaborate with Warehouse, Supply Chain, QC RM, and QA leadership to resolve issues.
• Adhere to SOPs and drive procedural improvements.

Skills

SAP

Microsoft Office

GMP quality systems

Data integrity

Communication

Multitasking

Education

Bachelor’s degree

Master’s degree

Tools

TrackWise

Job description

FUJIFILM Biotechnologies in North Carolina is seeking a QA Technical Specialist II to perform final disposition of GMP raw materials and consumables, ensuring timely availability for manufacturing. You will be the QA point of contact with Warehouse, Supply Chain, and QC RM, handling investigations, change controls, and supplier change notifications.

You will ensure data integrity and compliance with 21 CFR Part 820/Part 11, while collaborating with cross-functional teams to resolve issues and