QA Specialist, Drug Substance Manufacturing Ops

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 80,000 - 105,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Specialist for Drug Substance Manufacturing Operations (DSM) to oversee QA activities and validation programs for DSM processes. The role supports 2/2/3 shifts (6am-6pm) and ensures operations remain in a validated state throughout the lifecycle.

You will partner with teams to review batch records, triage deviations, and contribute to QA documentation and continuous improvement initiatives.

Qualifications

• Requires a life sciences or engineering degree with GMP experience.
• Experience in Validation and cGMP manufacturing operations in FDA-regulated facility.
• Familiarity with QA oversight of DSM processes and validation programs.
• Knowledge of regulatory requirements (21 CFR Part 11, Part 820) is preferred.

Responsibilities

• Provide QA oversight of DSM operations and ensure processes are in a validated state.
• Review batch records and solution records; perform exception-based oversight.
• Triage real-time deviations and implement immediate responses.
• Support development of QA documentation and procedures for manufacturing readiness.
• Collaborate with cross-functional teams to drive KPI achievement.
• Be flexible to support a 24/7 manufacturing facility and travel as needed.

Skills

QA oversight

Communication

Time management

GMP knowledge

Education

BS/BA Life Sciences or Engineering

Masters Life Sciences or Engineering

Tools

Trackwise

MasterControl

Kneat validation software

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Specialist for Drug Substance Manufacturing Operations (DSM) to oversee QA activities and validation programs for DSM processes. The role supports 2/2/3 shifts (6am-6pm) and ensures operations remain in a validated state throughout the lifecycle.

You will partner with teams to review batch records, triage deviations, and contribute to QA documentation and continuous improvement initiatives.