Senior Batch Record Review Specialist — Night Shift

Glaxosmithkline; Zebulon (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Onsite cafeteria

Onsite gym

Job summary

GSK Zebulon NC seeks a Senior Batch Record Review Specialist to ensure quality and regulatory compliance of manufactured products. You will review batch records, support investigations, and collaborate with production and QA teams to uphold high standards and continuous improvement.

This role partners with the LOC Quality Manager to maintain the QMS and align with GSK policies and local regulations. Additionally, you will handle certificate creation (C of A/C of M/C of C) and provide on-call

Qualifications

• Minimum high school diploma with 4+ years in pharmaceutical manufacturing/QA or an associate degree with 2+ years experience.
• 3+ years in batch record review, QA, or related regulated environment.
• Practical knowledge of GMP and GDP.
• Experience supporting deviation investigations, CAPAs, and batch releases.

Responsibilities

• Review, release, and second check batch record documentation for compliance with cGMPs, SOPs, and regulatory requirements.
• Coordinate investigations related to production deviations and close planned notifications as needed.
• Assist with NRFT issues for batch documents and provide quality guidance to production operations.
• Support self-inspections, internal audits and regulatory inspections.
• Create certificates of analysis (C of A), materials C of C, and review verification per market requirements with QA involvement.

Skills

Data Integrity

Detail Orientation

Quality Assurance

cGMP knowledge

GxP Regulations

Technical Writing

Education

Bachelor's degree in life sciences

Tools

MERP

LIMS

Microsoft Office

Job description

GSK Zebulon NC seeks a Senior Batch Record Review Specialist to ensure quality and regulatory compliance of manufactured products. You will review batch records, support investigations, and collaborate with production and QA teams to uphold high standards and continuous improvement.

This role partners with the LOC Quality Manager to maintain the QMS and align with GSK policies and local regulations. Additionally, you will handle certificate creation (C of A/C of M/C of C) and provide on-call