Night-Shift Senior Batch Records Lead (QA & Compliance)

NCBioImpact; Zebulon (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

GSK’s Zebulon site in North Carolina seeks a Senior Batch Record Review Specialist to ensure batch documentation meets cGMP and regulatory standards. You will join a quality-focused team, performing release checks and supporting investigations across production lines.

The role emphasizes collaboration with QA and production, continuous improvement, and readiness for regulatory inspections. Night shift Tue–Sat, offering growth within a global biopharma leader.

Qualifications

• Bachelor’s degree in life sciences or related field is preferred
• 4+ years experience in pharmaceutical manufacturing or quality assurance in a regulated setting
• Experience with GMP and GDP practices and documentation

Responsibilities

• Review, release, and second-check batch records for cGMP, SOP, and regulatory compliance
• Coordinate investigations related to production deviations; close Planned Notifications as needed
• Assist with NRFT issues for batch documents
• Provide quality guidance to production operations and review work orders and atypical comments
• Communicate effectively with team members and provide on-call support
• Support self-inspections, internal audits, and regulatory inspections
• Provide end-user support for GMP-related documentation corrections and drive continuous improvement
• Create certificates (C of A, C of M, C of C) aligned with market requirements and perform review and verification
• Set personal objectives aligned with quality strategy and personal development

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 or related field

High school diploma + 4 years pharma experience

Associate degree + 2 years pharma experience

Tools

MERP

LIMS

Microsoft Office

Job description

GSK’s Zebulon site in North Carolina seeks a Senior Batch Record Review Specialist to ensure batch documentation meets cGMP and regulatory standards. You will join a quality-focused team, performing release checks and supporting investigations across production lines.

The role emphasizes collaboration with QA and production, continuous improvement, and readiness for regulatory inspections. Night shift Tue–Sat, offering growth within a global biopharma leader.