Senior Batch Record Review Specialist (Nights)

GlaxoSmithKline plc; North Carolina; On-site; USD 70,000 - 100,000; Full time

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.

Skills

Batch record review

GMP/GDP knowledge

Quality assurance

CAPA investigations

Audit support

Documentation practices

Education

Bachelor's degree in life sciences or related field

Associate degree in a relevant field

Tools

MERP

LIMS

Microsoft Office

Job description

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance.

Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people.

Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary

Join us as a Senior Batch Record Review Specialist, where you will play a key role in ensuring the quality and compliance of manufactured products. You will review batch records to confirm they meet regulatory requirements and company standards. Collaborating closely with production and quality teams, you will help maintain high standards and support continuous improvement. This role offers you a chance to grow your expertise, contribute meaningfully to patient safety, and be part of GSK's mission of uniting science, technology, and talent to get ahead of disease together.

As a Senior Batch Record Review Specialist , you will be responsible for providing effective and efficient support to the Local Operating Country (LOC) Quality Manager to maintain effective Quality Management System (QMS) and perform LOC Quality Operation activities in compliance with GSK Policies, QMS and local regulations.

*This position will fill a Night Shift Tuesday - Saturday opportunity*

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Primarily responsible for review, release, and second check of batch record documentation for compliance to cGMPs, SOPs and internal and regulatory requirements.
• Coordinates investigations associated with production deviations, as needed. Closes Planned Notifications, as needed.
• Assists with issues of NRFT for batch documents.
• Provides quality guidance to production operations, completes work order assessments, and completes atypical comments.
• Communicates effectively with team members, escalates issues to production and quality team/lead, and provides on-call support, as needed.
• Supports self-inspections, internal audits and regulatory inspections.
• Provides end user support for GMP related documentation corrections. Supports continuous improvement processes.
• Responsible for certificate creation (C of A, C of M, C of C) in alignment with market requirements (TTS / Quality Agreements) along with review and second check verification.
• Agree personal objectives from the quality strategy and develops oneself.

Why you?

Basic Qualifications:

• High school diploma or equivalent, plus at least 4 years of relevant experience in pharmaceutical manufacturing or quality assurance; or an associate degree plus 2 years relevant experience.
• 3+ years experience in batch record review, quality assurance, or a related role within a regulated environment.
• Practical knowledge of GMP and Good Documentation Practices (GDP)
• Experience supporting deviation investigations, CAPAs, and batch release processes

Preferred Qualifications:

• Bachelor's degree in life sciences, quality, or a related field
• Strong attention to detail with clear written and verbal communication skills
• Proven ability to review manufacturing and laboratory records for compliance
• Experience with batch document review and supporting in inspections and audits.
• Experience working in a pharmaceutical environment with exposure to manufacturing processes and GMP principles
• Demonstrated serious commitment to accuracy, integrity and quality.
• Must be able to work independently but also be a strong team player.
• Entry level experience of MERP.
• To be able to identify, monitor and report documentation errors.
• To give advice to production staff, and others, on quality related issues and to promote GMP awareness by liaison with manufacturing and production staff.
• Knowledge of cGMP - FDA and other Regulatory requirements.
• Understanding of continuous improvement tools.
• Understanding of IT applications; i.e. MERP, Microsoft office, LIMS.
• Good communication skills.
• Good organizational skills.
• Knowledge of Pharmaceutical Processes

About the Zebulon Site

GSK's Zebulon site is a global supplier of Respiratory and Solid Dose medicines to patients around the globe and the largest GSK Pharmaceutical secondary manufacturing site in North A