QA Engineer, DSM Biotech Manufacturing (GMP)

NCBioImpact

Holly Springs (NC)

On-site

USD 110,000 - 150,000

Full time

3 days ago

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Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a QA Engineer for Drug Substance Manufacturing to provide quality oversight across DSM processes, ensuring validation status from development through startup to commercial operation. You will collaborate with global teams, prepare QA documentation, and support regulatory inspections in a cgMP environment.

Strong communication and validation experience are essential.

Qualifications

BS/BA in Life Sciences or Engineering with 5+ years in GMP.
MS in Life Sciences or Eng with 3+ years.
PhD in Life Sciences or Eng with 1+ year.
3+ years in a GMP regulated environment.
Experience with validation and quality oversight in FDA facilities.

Responsibilities

SME role developing DSM documentation, processes, and procedures.
Assess impact of changes and maintain validated state through startup to operations.
Oversee and approve lifecycle docs: specs, risk assessments, validation reports.
Create and approve QA procedures for validation approaches.
Prepare QA documentation supporting manufacturing readiness in cgMP facilities.
Ensure quality objectives meet timelines.
Collaborate with FUJIFILM sites to streamline processes.
Support regulatory inspections and improvement initiatives.
Perform other duties as assigned.