Senior Batch Record Review Specialist

GlaxoSmithKline

Zebulon, North Carolina, United States
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
** 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. **

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

** 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. **

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)

Work Rights

Not specified

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