QA Operations Specialist — cGMP Biotech Manufacturing

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 75,000 - 105,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC seeks a QA Specialist, Operations to oversee Quality systems for Drug Substance Manufacturing. You will validate DSM processes, maintain validation state, and support QA oversight of day-to-day operations in a cGMP facility.

Candidates should have GMP/QA experience, strong documentation skills, and ability to work cross-functionally in a Genki culture. Occasional travel and 24/7 support may be required.

Qualifications

• BS/BA in Life Sciences or Engineering or equivalent; 2+ years in GMP environment.
• Master's degree in Life Sciences or Engineering is a plus with 0+ years experience.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight in FDA-regulated facility.
• Familiar with GMP and data integrity practices and regulatory requirements.

Responsibilities

• Provide QA oversight and support DSM operations per governing processes.
• Review batch records and solution records with exception-based oversight.
• Perform real-time triage and implement immediate deviation responses.
• Support area changeovers and return to service activities.
• Collaborate with global peers and cross-functional teams to meet KPIs.

Skills

Communication skills

Time management

cGMP knowledge

English fluency

Team collaboration

Data Integrity awareness

Education

BS/BA Life Sciences or Engineering

Masters Life Sciences or Engineering

Tools

Smartsheet

TrackWise

MasterControl

Kneat

Job description

Fujifilm Biotechnologies in Holly Springs, NC seeks a QA Specialist, Operations to oversee Quality systems for Drug Substance Manufacturing. You will validate DSM processes, maintain validation state, and support QA oversight of day-to-day operations in a cGMP facility.

Candidates should have GMP/QA experience, strong documentation skills, and ability to work cross-functionally in a Genki culture. Occasional travel and 24/7 support may be required.