Senior QA Engineer, Drug Substance — GMP & Inspections

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC seeks a Senior QA Engineer, Drug Substance to provide quality assurance oversight during manufacturing, testing, storage, and distribution of drug substances. You will partner with Manufacturing, Quality, Supply Chain, and Facilities to ensure cGMP compliance and drive issue resolution.

You will review CAPAs, change controls, deviations, and participate in regulatory inspections, with opportunities to lead continuous improvement initiatives and coach

Qualifications

• Bachelor's degree in Life Sciences or Engineering with 9+ years of applicable industry experience.
• Master's degree in Life Sciences or Engineering with 6+ years of applicable experience.
• PhD in Life Sciences or Engineering and 3+ years of applicable experience.
• 5+ years of experience in GMP Quality Assurance and/or similar role.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility.
• Prior experience with Trackwise, Veeva, and/or Kneat validation software.
• Knowledge of electronic batch records and review-by-exception practices.
• Advanced understanding of drug substance manufacturing including cell culture, upstream and downstream processes.
• Expertise in cGMP & FDA regulations.
• Occasional travel may be available.

Responsibilities

• Provide QA oversight to ensure Drug Substance is manufactured, tested, stored, and distributed per cGMP, GDP and applicable regs.
• Review and approve cGMP processes, procedures, documents and records (BPRs, Deviations, CAPA).
• Author/review/approve quality documents (SOPs, risk assessments, training materials).
• Oversee on-the-floor analytical testing and ensure records meet procedures.
• Assist during audits/inspections by regulatory agencies; support inspections.
• Identify and implement continuous improvement opportunities within processes and systems.
• Provide project management support for system implementations and risk mitigation.

Skills

Quality assurance

cGMP knowledge

Cross-functional collaboration

Documentation control

Regulatory inspections

Root cause analysis

Project management

English communication

Education

Bachelor's degree in Life Sciences or Engineering

Master's degree in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Tools

Trackwise

Veeva

Kneat

MES

Delta-V

SAP

PI Data Historian

Job description

Fujifilm Biotechnologies in Holly Springs, NC seeks a Senior QA Engineer, Drug Substance to provide quality assurance oversight during manufacturing, testing, storage, and distribution of drug substances. You will partner with Manufacturing, Quality, Supply Chain, and Facilities to ensure cGMP compliance and drive issue resolution.

You will review CAPAs, change controls, deviations, and participate in regulatory inspections, with opportunities to lead continuous improvement initiatives and coach