Not specified; shift premium eligible for nights/w...
Onsite
4 years relevant pharmaceutical experience
3+ years batch record review experience
Practical knowledge of cgmp and gdp
GSK is seeking a Senior Batch Record Review Specialist for their Zebulon, North Carolina site, focusing on ensuring compliance with regulatory standards in batch record documentation. The role involves leading activities related to product release, providing quality guidance, and supporting continuous improvement processes within a regulated environment
Job Summary
This role leads batch record review activities to release products manufactured in compliance with regulatory agencies' requirements and company standards.
The position provides quality guidance to the Zebulon Production department and supports investigations associated with production deviations.
GSK offers a positive work environment with onsite amenities including a cafeteria, gym, and health clinic at the Zebulon site.
Matching Summary
Match Score: 85
GSK is seeking a Senior Batch Record Review Specialist for their Zebulon, North Carolina site, focusing on ensuring compliance with regulatory standards in batch record documentation. The role involves leading activities related to product release, providing quality guidance, and supporting continuous improvement processes within a regulated environment.
Salary
Not specified; Shift premium eligible for nights/weekends; Comprehensive benefits program offered
Skills & Requirements
Must-have
4 years relevant pharmaceutical experience
3+ years batch record review experience
Practical knowledge of cGMP and GDP
Experience with deviations and CAPA systems
Review of production and control records
Nice-to-have
Bachelor's degree in scientific discipline
Knowledge of FDA regulatory requirements
Understanding of continuous improvement tools
Experience with MERP and LIMS applications
Strong attention to detail and integrity
Key Requirements
High School Diploma plus 4 years relevant experience OR Associates degree plus 2 years
3+ years experience in batch record review or quality assurance