QA Engineer, Drug Substance - Quality & Compliance Lead

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Engineer, Drug Substance to oversee drug substance manufacturing quality per cGMP/GDP, collaborate with Manufacturing and Quality teams, and support audits and inspections.

The role emphasizes coaching, guidance, and cross-functional partnership to ensure quality, implement improvements, and drive regulatory readiness across the organization.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering with 5+ years of applicable industry experience.
• Master’s degree in Life Sciences or Engineering with 3+ years of applicable experience.
• PhD in Life Sciences or Engineering with 1+ years of applicable experience.
• 2+ 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 QA oversight to ensure Drug Substance is manufactured, tested, stored, and distributed per cGMP and GDP.
• Review and approve cGMP processes, documents and records (BPRs, Deviations, CAPAs).
• Author/review/approve quality documents (SOPs, risk assessments, training materials).
• Oversee on-the-floor analytical testing and ensure records are complete and compliant.
• Ensure changes impacting product quality are assessed per procedures.
• Investigate deviations per procedures and document findings.
• Support regulatory inspections and interactions with authorities.
• Lead continuous improvement initiatives and system implementations.

Skills

Quality assurance

GxP compliance

Cross-functional collaboration

Problem solving

Regulatory knowledge

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

SAP

PI data historian

MES

Delta-V

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Engineer, Drug Substance to oversee drug substance manufacturing quality per cGMP/GDP, collaborate with Manufacturing and Quality teams, and support audits and inspections.

The role emphasizes coaching, guidance, and cross-functional partnership to ensure quality, implement improvements, and drive regulatory readiness across the organization.