Specialist, QA OTF
Core
Specialist in Quality Assurance On-The-Floor (QA OTF) providing real-time quality oversight, documentation review, and compliance monitoring for GMP manufacturing of cell banks, biological bulk drug substances, and finished drug products.
Role type
Specialist, QA OTF (On-the-Floor Quality Assurance)
Builds
Master and working cell banks, biological bulk drug substances, and finished drug products for human use
Domain
Biopharmaceuticals / Cell & Gene Therapy
Required skills
GMP compliance, deviation management, batch record review, aseptic technique monitoring, audit execution, risk identification, regulatory knowledge (21 CFR, ICH, EU GMP), troubleshooting
Preferred skills
Manufacturing or Quality experience, Trackwise system knowledge, electronic batch records experience
Technologies
Trackwise, electronic batch record systems
Responsibilities
Partner with manufacturing teams to maintain floor presence for real-time quality oversight; Perform room release and observe critical manufacturing processes; Conduct routine audits of manufacturing, warehouse, and support areas; Monitor adherence to cGMP, QMS, and aseptic behaviors; Review manufacturing documentation and batch records for accuracy; Provide QA oversight including AQL visual inspections; Escalate issues and drive continuous improvement; Serve as a quality resource for GMP personnel
Seniority
Specialist, hands-on IC