QA Operations Specialist, cGMP & Validation

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Specialist, Operations to provide QA oversight of Drug Substance Manufacturing processes and validate DSM systems throughout their lifecycle. You will participate in batch and solution record reviews, real-time event triage, and KPI-driven objectives, while supporting cGMP manufacturing and continuous improvement across sites.

This role requires 2+ years GMP experience or a master’s with related experience, and familiarity with validation

Qualifications

• BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience
• Masters in Life Sciences or Engineering or equivalent 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, including exception-based oversight using Quality Review Management tool
• Real time event triage and implementation of immediate response to identified deviations
• Area changeover and return to service
• Real time WO oversight per applicable procedures
• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs
• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites
• Works 12-hour shift on 2-2-3 cadence, 0600-1800
• Perform other duties, as assigned

Skills

Quality Assurance

GMP

Communication

Education

BS/BA Life Sciences or Engineering

Masters in Life Sciences or Engineering

Tools

Trackwise

MasterControl

Kneat

Smartsheet

ASTM E2500

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Specialist, Operations to provide QA oversight of Drug Substance Manufacturing processes and validate DSM systems throughout their lifecycle. You will participate in batch and solution record reviews, real-time event triage, and KPI-driven objectives, while supporting cGMP manufacturing and continuous improvement across sites.

This role requires 2+ years GMP experience or a master’s with related experience, and familiarity with validation