Senior Batch Record Review Specialist

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:

You will lead batch record review activities to Release product that is manufactured and/or packaged in compliance with regulatory agencies’ requirements and company standards. Provide quality guidance to Zebulon Production department to ensure their activities are in compliance with regulatory agencies’ requirements and company standards.

Responsibilities:

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. Supports Problem Solving/Root Cause Analysis to identify Root Causes and appropriate CAPAs for identified problems. Supports OQ training.

• Provides end user support for GMP related documentation corrections.

• Supports continuous improvement processes.

• Supports certificate (CofA, CofC) creation, review and second check verification in alignment with market requirements and GSK standards along with.

• Agree personal objectives from the quality strategy and develops oneself.

Basic Qualifications:

• High School Diploma plus 4 years relevant experience in the pharmaceutical industry, with a production or quality background or an associate's degree plus 2 years relevant experience in the pharmaceutical.

• BS/BA degree with 2 years relevant experience in the pharmaceutical industry

• 3+ years' experience in batch record review, quality assurance, or operations within a regulated life sciences environment.

• Practical knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

• Experience reviewing production, laboratory, and control records for compliance.

• Experience with quality systems such as deviations, CAPA, change control, and lot release.

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Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Bachelor’s degree in a scientific, engineering, or quality discipline.

• 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.

• Strong attention to detail, clear written communication, and the ability to follow procedures.

• Demonstrated serious commitment to accuracy, integrity and quality.

• Must be able to work independently but also be a strong team player.

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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, Wilson, and Wake Forest.  

Key differentiators about GSK and Zebulon: 

• Our commitment to inclusion is seen 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 climate                                  

• Licensed, onsite Health & Wellness clinic 

Work arrangement:

This position is on-site and may require some nights or weekend work. Shift work on Nights or weekends is eligible to receive a shift premium for work during those scheduled hours.

What we value:

We look for people who act with integrity, put patients first, and work well with others. We welcome applicants from all backgrounds and encourage people who bring different perspectives to apply. If you are ready to grow your career, deepen your quality expertise, and make a real impact, please apply and tell us how your experience fits this role.

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#GSKCareers

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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