QA Specialist (Hybrid)
$66,200–$86,800 year
HybridRaleigh, North Carolina, United States
Job Summary
QA Specialist, External Manufacturing Quality Operations (EMQO) at Eisai Raleigh facility oversees QA activities under supervision, contributing to batch record review, documentation management, investigation support, and quality system tasks to ensure cGMP/compliance. Responsibilities include archival of documents in Veeva Vault, developing and maintaining quality procedures, managing electronic records, reviewing manufacturing batch records for accuracy and disposition support, coordinating documentation readiness for release, supporting deviation/inspection activities, collaborating with QA partners and cross-functional teams, participating in audits/inspections, tracking quality metrics, and contributing to continuous improvement. Requires a Bachelor’s degree in a relevant scientific field with 2+ years in QA in an FDA-regulated environment or equivalent experience; familiarity with QMS (Veeva, TrackWise); GMP QA functions (batch records, release, archival); knowledge of GMP regulations; SAP experience; strong organizational/communication/technical writing skills; ability to work a hybrid schedule (minimum 3 onsite days: Tue, Wed, Thu). Eisai salary transparency applies; equal opportunity employer.
Required Qualifications
- Bachelor’s degree in a relevant scientific field with 2+ years of related in Quality Assurance in an FDA-regulated industry OR equivalent education and work experience
- Experience or familiarity with Quality Management Systems (e.g., Veeva, TrackWise)
- Demonstrated experience across key quality assurance functions in a GMP setting (e.g., batch record review, batch release functions, GxP document archival, as applicable)
- Knowledge and experience working with quality regulations to own area (e.g., experience working with regulated GMP systems and relevant health authorities)
- Experience or familiarity with SAP inventory system
- Proficient in Microsoft Office tools
- Proven performance in earlier role
- Biologics experience preferred
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