New · posted Nov 11
GSK · Pharmaceuticals
Operational Quality Specialist (Nights)
- Zebulon, NC
- On-site
- Full-time
- Senior & Principal
The role
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.
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.
Ready to apply?
If this role matches your skills and career goals, please apply. Share how your experience aligns with the responsibilities and qualifications. Tell us how you helped improve quality processes or contributed to team success. We value your unique perspective and look forward to exploring how you can make a real difference for patients with us.
What you need
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
- 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
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.
Preferred Qualificationsnice to have
If you have the following characteristics, it would be a plus:
- 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
Pay and benefits
GSK didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Onsite cafeteria
Onsite gym
Licensed onsite Health & Wellness clinic
Where you'll work
Zebulon, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Zebulon, NC
From the posting
About GSK
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
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 - [email protected]
Equal opportunity, accessibility and legal noticesGSK's statements, word for word
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
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.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US22 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $93,625 | $96,500 | $116,000 |
Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 106 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not GSK's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 39 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance12
- Documentation and SOPs11
- Collaboration and leadership7
- Quality systems and risk4
- Investigations and CAPA2
- Data and digital systems2
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in pharmaceuticals, led by the four this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality AgreementsNamed in the posting
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human useNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
GSK on Regulatory Jobs
- 39
- Open roles
- 39
- Distinct roles
- 8
- Locations
By discipline
- Clinical19 49%
- Quality14 36%
- Regulatory6 15%
By level
- Director21 54%
- Associate & Specialist8 21%
- Manager4 10%
More roles at GSK
- View role
Operational Quality Specialist
Marietta, PAAssociate & SpecialistPharmaceuticalsSalary not listed
- View role
Operational Quality Specialist - MES
Marietta, PAAssociate & SpecialistPharmaceuticalsSalary not listed
- View role
Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology
Upper Providence, PA · HybridDirectorPharmaceuticals$222K–$370K
- View role
Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation)
United States +2 more · HybridDirectorPharmaceuticals$139K–$231K
Similar Quality Operations & Batch Release roles elsewhere
- View role
QA Specialist III - Quality on the Floor (QOTF)
Thermo Fisher ScientificGreenville, NCSenior & PrincipalPharmaceuticalsSalary not listed
- View role
QA Specialist - Batch Release Officer
ICONRaleigh, NCSenior & PrincipalPharmaceuticalsSalary not listed
- View role
Sr. Specialist, Quality Assurance (Nights)
Cardinal HealthJackson, MSSenior & PrincipalPharmaceuticals$60K–$77K
- View role
Senior Specialist - Quality Assurance - Nights
Cardinal HealthColton, CASenior & PrincipalPharmaceuticals$77K–$99K
Operational Quality Specialist (Nights) at GSK
Applications close November 15.