Drug Substance QA Engineer - Compliance & Quality

Merck & Co.; Holly Springs (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC, seeks a QA Engineer for Drug Substance to oversee quality across manufacturing, testing, and distribution, ensuring adherence to cGMP and GDP. You will guide Manufacturing, Quality Control, and Facilities staff, supporting audits and inspections.

The role emphasizes coaching, issue resolution, and driving continual improvements within QA and manufacturing processes in a multi-disciplinary setting.

Qualifications

• Bachelor's degree in Life Sciences or Engineering with 5+ years of applicable industry experience; OR Master’s with 3+ years; OR PhD with 1+ year.

Responsibilities

• Provide quality oversight to ensure Drug Substance is manufactured, tested, stored, and distributed per cGMP and GDP.

Skills

Regulatory knowledge

cGMP biotech manufacturing

Cross-functional collaboration

Excellent communication

Attention to detail

Problem solving

Mentoring

GAMP5 knowledge

21 CFR Part 820/11

MES/Automation familiarity

Education

Bachelor's in Life Sciences or Engineering

Master's in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Tools

Trackwise

Veeva

Kneat

Job description

Fujifilm Biotechnologies in Holly Springs, NC, seeks a QA Engineer for Drug Substance to oversee quality across manufacturing, testing, and distribution, ensuring adherence to cGMP and GDP. You will guide Manufacturing, Quality Control, and Facilities staff, supporting audits and inspections.

The role emphasizes coaching, issue resolution, and driving continual improvements within QA and manufacturing processes in a multi-disciplinary setting.