Senior Batch Record QA Lead (Night Shift)

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

Benefits offered by this job

Onsite cafeteria

Onsite gym

Health & Wellness clinic

Job summary

GSK Zebulon site in North Carolina seeks a Senior Batch Record Review Specialist for a night shift Tuesday–Saturday. You will review batch records to ensure regulatory compliance and company standards, while collaborating with production and quality teams to sustain high quality and implement improvements.

Responsibilities include supporting deviations, CAPAs, audits, and document corrections, with emphasis on data integrity and GxP adherence.

Qualifications

• High school diploma or equivalent with 4+ years in pharma manufacturing or QA.
• 3+ years in batch record review or QA in a regulated environment.
• GMP and GDP knowledge and application.
• Experience supporting deviation investigations, CAPAs, and batch release.

Responsibilities

• Review, release, and second-check batch records for cGMP and regulatory compliance.
• Coordinate investigations for production deviations and close planned notifications.
• Support NRFT issues for batch documents and provide quality guidance to production.
• Assist with inspections, audits, and continuous improvement activities.
• Create certificates (C of A/C of M/C of C) aligned with market requirements.
• Set personal objectives aligned with quality strategy and develop professionally.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance

Risk Awareness

Technical Writing

Education

Bachelor’s degree in life sciences

Associate degree

Tools

MERP

Microsoft Office

LIMS

Job description

GSK Zebulon site in North Carolina seeks a Senior Batch Record Review Specialist for a night shift Tuesday–Saturday. You will review batch records to ensure regulatory compliance and company standards, while collaborating with production and quality teams to sustain high quality and implement improvements.

Responsibilities include supporting deviations, CAPAs, audits, and document corrections, with emphasis on data integrity and GxP adherence.