Senior QA Engineer - Drug Substance Operations Lead

FUJIFILM; Holly Springs (AL); On-site; USD 120,000 - 180,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking a Senior QA Engineer, Drug Substance to provide quality assurance oversight during drug substance operations at our Holly Springs facility. You will collaborate with Manufacturing, Quality Control, Supply Chain, and Facilities to ensure compliance with cGMP, GDP, and regulatory requirements and support timely inspections and post-audit actions.

The role emphasizes coaching, process improvement, and risk mitigation while working with cross-functional teams to

Qualifications

• Bachelor’s degree in Life Sciences or Engineering with 9+ years of applicable industry experience; OR, Master’s with 6+ years; OR, PhD with 3+ years.
• 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.

Responsibilities

• Provide quality oversight to ensure Drug Substance is manufactured, tested, stored, and distributed per cGMP, GDP, and applicable regulations.
• Review and approve cGMP processes, procedures, documents and records (BPRs, Deviations, CAPA, etc.).
• Author/review/approve quality documents (SOPs, risk assessments, training materials, validation reports).
• Provide on-the-floor analytical testing guidance and ensure records meet written procedures.

Skills

Quality Assurance

cGMP

FDA regulations

Documentation

Problem solving

Cross-functional collaboration

Mentoring

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

Job description

FUJIFILM Biotechnologies is seeking a Senior QA Engineer, Drug Substance to provide quality assurance oversight during drug substance operations at our Holly Springs facility. You will collaborate with Manufacturing, Quality Control, Supply Chain, and Facilities to ensure compliance with cGMP, GDP, and regulatory requirements and support timely inspections and post-audit actions.

The role emphasizes coaching, process improvement, and risk mitigation while working with cross-functional teams to