QA Operations Specialist — GMP & Validation Focus

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

FUJIFILM Biotechnologies, based in Holly Springs, NC, seeks a QA Specialist, Operations to oversee QA for Drug Substance Manufacturing processes and validate DSM programs. The role ensures QA oversight of daily activities and rapid resolution of deviations in a 24/7 clinical biotech setting.

The ideal candidate has 2+ years in GMP environments or a Master’s in Life Sciences/Engineering with entry-level experience, and strong knowledge of cGMP, 21 CFR Part 11, and data integrity.

Qualifications

• BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience; OR, Masters in Life Sciences or Engineering with 0 years’ relevant experience.
• 1-3 years’ experience in a GMP environment.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.

Responsibilities

• Provides QA oversight and supports DSM operations in accordance with governing processes and procedures.
• Provides QA support of DSM tasks such as batch record and solution lot record review, exception-based oversight, real-time event triage, and deviation response.
• Ensures department objectives are met within timelines and KPIs.
• Contributes to QA documentation, procedures, and processes for operational readiness and QA support of manufacturing operations.

Skills

QA Oversight

cGMP compliance

Documentation

Communication

GAMP5

Data Integrity

21 CFR Part 11

Education

BS/BA Life Sciences or Engineering

Masters Life Sciences or Engineering

Tools

Trackwise

MasterControl

Kneat

Smartsheet

ASTM E2500

Job description

FUJIFILM Biotechnologies, based in Holly Springs, NC, seeks a QA Specialist, Operations to oversee QA for Drug Substance Manufacturing processes and validate DSM programs. The role ensures QA oversight of daily activities and rapid resolution of deviations in a 24/7 clinical biotech setting.

The ideal candidate has 2+ years in GMP environments or a Master’s in Life Sciences/Engineering with entry-level experience, and strong knowledge of cGMP, 21 CFR Part 11, and data integrity.