Not specified; shift premium eligible for nights/w...
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4 years pharmaceutical industry experience
3+ years batch record review experience
Practical knowledge of gmp and gdp
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GlaxoSmithKline is seeking a Senior Batch Record Review Specialist in Zebulon, North Carolina, to oversee compliance in batch record documentation for pharmaceuticals and vaccines. The ideal candidate will have experience in quality assurance within a regulated environment and a commitment to safety and quality.
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Job Summary
This role leads batch record review activities to ensure product release complies with regulatory agencies' requirements and company standards.
The position involves coordinating investigations for production deviations, closing planned notifications, and supporting root cause analysis for CAPAs.
GSK offers a commitment to inclusion, onsite amenities including a gym and cafeteria, and opportunities for career growth at the Zebulon site.
Matching Summary
Match Score: 75
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GlaxoSmithKline is seeking a Senior Batch Record Review Specialist in Zebulon, North Carolina, to oversee compliance in batch record documentation for pharmaceuticals and vaccines. The ideal candidate will have experience in quality assurance within a regulated environment and a commitment to safety and quality.
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Salary
Not specified; Shift premium eligible for nights/weekends
Skills & Requirements
Must-have
4 years pharmaceutical industry experience
3+ years batch record review experience
Practical knowledge of GMP and GDP
Experience reviewing production records
Knowledge of deviations CAPA change control
Nice-to-have
Bachelor's degree in scientific discipline
Understanding of continuous improvement tools
Experience with MERP LIMS Microsoft Office
Strong attention to detail and integrity
Ability to work independently as team player
Key Requirements
High School Diploma plus 4 years relevant experience
Associates degree plus 2 years relevant experience
3+ years experience in batch record review or QA
US work authorization required (implied by location)