Senior Batch Record Review Specialist (Nights)

Glaxosmithkline; Zebulon (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Onsite cafeteria

Onsite gym

Job summary

GSK Zebulon NC seeks a Senior Batch Record Review Specialist to ensure quality and regulatory compliance of manufactured products. You will review batch records, support investigations, and collaborate with production and QA teams to uphold high standards and continuous improvement.

This role partners with the LOC Quality Manager to maintain the QMS and align with GSK policies and local regulations. Additionally, you will handle certificate creation (C of A/C of M/C of C) and provide on-call

Qualifications

• Minimum high school diploma with 4+ years in pharmaceutical manufacturing/QA or an associate degree with 2+ years experience.
• 3+ years in batch record review, QA, or related regulated environment.
• Practical knowledge of GMP and GDP.
• Experience supporting deviation investigations, CAPAs, and batch releases.

Responsibilities

• Review, release, and second check batch record documentation for compliance with cGMPs, SOPs, and regulatory requirements.
• Coordinate investigations related to production deviations and close planned notifications as needed.
• Assist with NRFT issues for batch documents and provide quality guidance to production operations.
• Support self-inspections, internal audits and regulatory inspections.
• Create certificates of analysis (C of A), materials C of C, and review verification per market requirements with QA involvement.

Skills

Data Integrity

Detail Orientation

Quality Assurance

cGMP knowledge

GxP Regulations

Technical Writing

Education

Bachelor's degree in life sciences

Tools

MERP

LIMS

Microsoft Office

Job description

Business Introduction

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?

We are looking for professionals with these required skills to achieve our goals:

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 America. The site is located less than 30 minutes from downtown Raleigh, Wendell, Knightdale, Rocky Mount and Wake Forest.

Key differentiators about GSK and Zebulon

• Our commitment to inclusion and diversity - we see diversity as a critical advantage of ours
• Our focus on cultivating a positive work environment that cares for our employees
• Demonstrated opportunities for continued career growth driven by individual ambition
• Leaders that care about their teams and growth of both individuals and the company
• A priority focus on Safety and Quality
• Clean and GMP compliant work environment
• Onsite cafeteria
• Onsite gym
• Temperature-controlled
• Licensed onsite Health & Wellness clinic

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

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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