Senior Batch Record Quality Reviewer Night Shift

GlaxoSmithKline plc; Zebulon (GA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Onsite cafeteria

Onsite gym

Temperature-controlled onsite Health &

Wellness clinic

Job summary

GlaxoSmithKline plc is seeking a Senior Batch Record Review Specialist for our Zebulon, GA site to ensure quality and regulatory compliance of manufactured products. You will review and release batch documentation, support deviations, and provide quality guidance to production operations, contributing to patient safety and a robust QMS.

The role collaborates with production and quality teams, supports internal and regulatory inspections, and participates in continuous improvement initiatives.

Qualifications

• High school diploma or equivalent, plus 4+ years in pharma manufacturing or QA; or an associate degree plus 2+ years.
• 3+ years experience in batch record review, QA, or related role in regulated environment.
• Practical knowledge of GMP and GDP; experience supporting deviation investigations, CAPAs, and batch releases.

Responsibilities

• Review, release, and second check of batch record documentation for compliance to cGMPs, SOPs and regulatory requirements.
• Coordinate investigations related to production deviations as needed.
• Close Planned Notifications as needed.
• Assist with NRFT issues for batch documents.
• Provide quality guidance to production operations and complete work order assessments.
• Communicate effectively with team members and provide on-call support as needed.
• Support self-inspections, internal audits and regulatory inspections.
• Provide end-user support for GMP documentation corrections.
• Support continuous improvement processes.
• Create certificates (C of A, C of M, C of C) per market requirements and perform review and second check verification.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Education

Bachelor's degree in life sciences

Associate degree in Life Sciences

High School Diploma or equivalent

Tools

MERP

Microsoft Office

LIMS

Job description

GlaxoSmithKline plc is seeking a Senior Batch Record Review Specialist for our Zebulon, GA site to ensure quality and regulatory compliance of manufactured products. You will review and release batch documentation, support deviations, and provide quality guidance to production operations, contributing to patient safety and a robust QMS.

The role collaborates with production and quality teams, supports internal and regulatory inspections, and participates in continuous improvement initiatives.