Night-Shift Senior Batch Record Quality Specialist

GlaxoSmithKline plc

North Carolina

On-site

USD 70,000 - 100,000

Full time

4 days ago

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Job summary

GlaxoSmithKline plc in Zebulon, NC is seeking a Senior Batch Record Review Specialist to ensure the quality and regulatory compliance of manufactured medicines. You will review batch records, release documentation, and support QA operations with production teams to uphold high standards and patient safety.

This night-shift role (Tuesday to Saturday) offers exposure to cGMPs, deviations investigations, CAPAs, audits, and continuous improvement.

Qualifications

4+ years in pharmaceutical batch record review or a related QA role.
Knowledge of GMP and GDP practices and regulatory requirements.
Experience supporting deviations investigations and CAPAs.
Experience with batch release processes and inspections.

Responsibilities

Review, release, and second-check batch record documentation for GMP and regulatory compliance.
Coordinate investigations of production deviations and 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 teams and provide on-call QA support.
Support self-inspections, internal audits, and regulatory inspections.
Create certificates of analysis, certificates of modification, and certificates of conformity in alignment with market requirements.
Set objectives from the quality strategy and develop yourself.