QA Materials Disposition Specialist – GMP & SAP

Merck & Co.; North Carolina; Hybrid; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid vacation and holidays

Employee assistance programs

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 serve as the QA contact for Warehouse, Supply Chain, and QC Raw Materials, handling investigations and quality impact assessments.

Responsibilities include disposition in SAP, updating material records, contributing to deviations and change controls, and maintaining data integrity while

Qualifications

• 9+ years of industry experience with relevant GMP quality systems.
• Experience working within GMP quality systems (deviations, change control, investigations).
• Hands‑on experience with SAP (material status/transactions) and Microsoft Office.

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

SAP

TrackWise

GxP

Microsoft Office

Quality systems

Education

Bachelor's degree

Associate's degree

High School Diploma

Master's degree

Tools

TrackWise

SAP

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 serve as the QA contact for Warehouse, Supply Chain, and QC Raw Materials, handling investigations and quality impact assessments.

Responsibilities include disposition in SAP, updating material records, contributing to deviations and change controls, and maintaining data integrity while