QA Engineer, Drug Substance — Onsite GMP Quality & Compliance

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 100,000 - 160,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a QA Engineer, Drug Substance to provide quality assurance oversight across manufacturing, testing, and distribution in a cGMP environment. You will partner with Manufacturing and Quality teams to guide deviations, inspections, and continuous improvement initiatives.

You will review and approve cGMP documents, lead on-the-floor testing support, and mentor staff while ensuring compliance with FDA regulations and data integrity requirements.

Qualifications

• 5+ years of GMP Quality Assurance experience or similar role.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
• 2+ years of experience in GMP Quality Assurance and/or similar role.

Responsibilities

• Provide QA oversight to ensure Drug Substance is manufactured, tested, stored, and distributed per cGMP/GDP regulations.
• Review and approve cGMP processes, documents, records, and change controls.
• Author/review/approve quality documents (SOPs, risk assessments, training materials, engineering documents, etc.).
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure production records and testing results are complete, accurate, and documented.
• Ensure that deviations are investigated and documented per procedures.
• Alert senior management of quality, compliance, risks.
• Support project management and system implementation efforts.
• Identify and implement continuous improvement opportunities.
• Support and represent manufacturing QA during audits/inspections.

Skills

Communication skills

Detail oriented

Problem solving

Mentoring

English fluency

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 is seeking a QA Engineer, Drug Substance to provide quality assurance oversight across manufacturing, testing, and distribution in a cGMP environment. You will partner with Manufacturing and Quality teams to guide deviations, inspections, and continuous improvement initiatives.

You will review and approve cGMP documents, lead on-the-floor testing support, and mentor staff while ensuring compliance with FDA regulations and data integrity requirements.