QA Specialist, Drug Product

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us deliver the next vaccine, cure, or therapy in a dynamic work environment that fuels purpose, energy, and drive—what we call Genki.

About the role

The QA Specialist, Drug Product (DP) drives Quality oversight for all DP Manufacturing processes from project phase through operational readiness. This role oversees QA’s day-to-day activities, resolves or mitigates issues, and ensures Manufacturing systems remain in a validated state from startup into commercial operation.

Responsibilities

• Supports the development of documents, processes, and procedures for the Drug Product program.
• Assesses the impact of system and process modifications and maintains oversight of change management processes.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product and process equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Generates, reviews, and approves QA procedures for validation approaches and lifecycle documents for Manufacturing Systems.
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in a cGMP-regulated facility.
• Ensures fulfillment of project and operational quality objectives within desired timelines.
• Provides Manufacturing shop floor support, including Acceptable Quality Limit (AQL), critical process step verification, issue resolution, line clearance, and alarm response.
• Participates in optimization or improvement initiatives; supports regulatory agency and third-party inspections.
• Performs other duties as assigned.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or equivalent with 2+ years of applicable industry experience; OR, Master’s degree in Life Sciences or Engineering with 0+ years of applicable experience.
• 1+ years of experience working in a GMP-regulated environment.
• Experience in Validation, cGMP manufacturing operations, and/or Quality oversight in an FDA-regulated facility.
• Flexibility to support a 24/7 manufacturing facility.
• Occasional opportunities for international and/or domestic travel.

Skills

• Excellent verbal and written communication skills to partner with diverse teams and stakeholders; fluency in English.
• Strong time management and ability to meet tight deadlines.
• Critical thinking and superior problem-solving skills.
• Collaborative attitude; willingness to work with global peers and cross-functional teams.
• Basic knowledge and application of cGMP compliance and related regulations.
• Ability to fully embrace a Genki culture and bring positive energy to a dynamic work environment.

Preferred Qualifications

• High-level understanding of validation of production equipment, hygienic utilities, quality systems, automation, methodologies, manufacturing, and IT Systems.
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11.
• Understanding of formulation, aseptic filling, and/or visual inspection.
• Working knowledge and experience with ASTM E2500, Smartsheet, Trackwise, Veeva, Kneat validation software, and/or PAS-X.
• Experience with startup projects or initiatives.

Working Conditions & Physical Requirements

• Ability to discern audible cues.
• Ability to inspect or perform tasks with 20/20 corrected vision, including color distinction.
• Ability to stand or sit for prolonged periods (up to 120 minutes).
• Ability to conduct activities using repetitive motions of wrists, hands, and/or fingers.
• Ability to move objects up to 10 pounds.
• Ability to bend, push, pull, reach (18” to 60” in height), and use twisting motions.
• Work in warm/cold environments (2-8°C).