QA Specialist, Drug Substance Ops — 2/2/3 Shift
FUJIFILM
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Job summary
FUJIFILM Biotechnologies in Holly Springs is seeking a QA Specialist for DSM Operations to oversee QA activities, validate DSM processes, and ensure compliance across the manufacturing lifecycle. You will review records, triage deviations, and support documentation development in a fast-paced, 24/7 manufacturing environment.
Ideal candidates have GMP QA experience, familiarity with cGMP and data integrity, and ability to work with global teams across sites.
Qualifications
- 2+ years of GMP experience in QA or manufacturing.
- Experience with validation in FDA-regulated facilities.
- BS/BA in Life Sciences or Engineering; OR Masters in Life Sciences or Engineering with 0+ years of experience.
Responsibilities
- Provide QA oversight of DSM operations in accordance with governing processes and procedures.
- Review Batch Record and Solution Lot Record, including deviation oversight.
- Perform real-time event triage and implement immediate response to deviations.
- Develop QA documentation, procedures, and processes for cGMP manufacturing readiness.
- Collaborate to streamline quality processes across FUJIFILM Biotechnologies sites.
Skills
Education
Tools
Job description
FUJIFILM Biotechnologies in Holly Springs is seeking a QA Specialist for DSM Operations to oversee QA activities, validate DSM processes, and ensure compliance across the manufacturing lifecycle. You will review records, triage deviations, and support documentation development in a fast-paced, 24/7 manufacturing environment.
Ideal candidates have GMP QA experience, familiarity with cGMP and data integrity, and ability to work with global teams across sites.
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