QA Operations Specialist - GMP & Validation

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Specialist, Operations to oversee DSM processes and QA validation activities. You will ensure validated state across lifecycle, support real-time deviations, and contribute to QA documentation and processes for manufacturing readiness.

You will collaborate with global peers, support 24/7 manufacturing needs, and participate in efficiency initiatives across FUJIFILM Biotechnologies sites.

Qualifications

• BS/BA in Life Sciences or Engineering or equivalent; 2+ years relevant exp.
• Masters in Life Sciences or Engineering or equivalent; 0 years relevant exp.
• 1–3 years in a GMP environment with validation/QA oversight.

Responsibilities

• Provide QA oversight of DSM operations and governing processes.
• Review Batch Records and Solution Lot Records; oversee deviations.
• Real-time event triage and immediate response to deviations.
• Oversee area changeover and return to service.
• Real-time work order oversight per procedures.
• Support development of QA docs and processes for operational readiness.
• Assist efficiency initiatives across FUJIFILM sites.
• Perform other duties as assigned.

Skills

QA Oversight

DSM Operations

Batch Review

Real‑time triage

cGMP compliance

Data Integrity

Cross‑functional

Education

BS/BA Life Sciences or Engineering

Masters in Life Sciences or Engineering

1–3 years GMP experience

Tools

Trackwise

MasterControl

Kneat

Smartsheet

ASTM E2500

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Specialist, Operations to oversee DSM processes and QA validation activities. You will ensure validated state across lifecycle, support real-time deviations, and contribute to QA documentation and processes for manufacturing readiness.

You will collaborate with global peers, support 24/7 manufacturing needs, and participate in efficiency initiatives across FUJIFILM Biotechnologies sites.