Validation QA Specialist - Biopharma GMP

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Specialist, Validation to drive quality oversight for commissioning and qualification activities. You will review and approve validation documents, maintain validated states, and support change control in a GMP environment.

The role emphasizes risk assessment, lifecycle documentation, and cross‑functional collaboration with global teams. Occasional travel may be required, with a strong emphasis on 24/7 manufacturing readiness.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering with 2 years of applicable industry experience; OR Master’s degree with no previous experience.
• 1-3 years of experience working in a GMP regulated environment.
• Experience in Validation and/or Quality oversight, in an FDA regulated facility.

Responsibilities

• Performs a role within the QA team for the development of documents, processes, and procedures for the Validation program.
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure facilities, utilities and equipment are first validated and then maintained in a validated state.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, user requirements, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for facilities, utilities and equipment.
• Generates, reviews, and approves QA documentation, procedures, and processes for QA support of manufacturing operations in cGMP regulated facility.
• Ensures project and operational quality objectives are met within desired timelines.
• Manufacturing (Clean Room) shop floor support for issue resolution, as needed.
• Participates in optimization or improvement initiatives and supports regulatory agency and third‑party inspections.
• Must be flexible to support 24/7 manufacturing facility.
• Performs other duties, as assigned.

Skills

GMP compliance

Validation

Change management

Documentation review

Quality oversight

cGMP

Communication

Education

Bachelor’s degree in Life Sciences or Engineering

Master’s degree in Life Sciences or Engineering

Tools

Trackwise

Smartsheets

Veeva

Kneat validation

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Specialist, Validation to drive quality oversight for commissioning and qualification activities. You will review and approve validation documents, maintain validated states, and support change control in a GMP environment.

The role emphasizes risk assessment, lifecycle documentation, and cross‑functional collaboration with global teams. Occasional travel may be required, with a strong emphasis on 24/7 manufacturing readiness.