# Senior Batch Record Review Specialist

**Company**: GSK
**Location**: Zebulon, North Carolina
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Category**: Manufacturing
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---North-Carolina---Zebulon/Senior-Batch-Record-Review-Specialist--Nights-_450903?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/senior-batch-record-review-specialist-02db9367-a2e/

## Description

Join GSK as a Senior Batch Record Review Specialist, playing 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 with production and quality teams to maintain high standards and support continuous improvement.

Responsibilities:

- Review, release, and second-check batch record documentation for compliance with cGMPs, SOPs, and internal and regulatory requirements

- Coordinate investigations associated with production deviations and close Planned Notifications as needed

- Assist with issues of NRFT for batch documents and provide quality guidance to production operations

- Complete work order assessments and atypical comments

- Communicate effectively with team members, escalate issues to production and quality teams, and provide on-call support as needed

- Support self-inspections, internal audits, and regulatory inspections

- Provide end-user support for GMP-related documentation corrections and support continuous improvement processes

- Create certificates (C of A, C of M, C of C) in alignment with market requirements

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 of relevant experience

- 3+ years of 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 inspections and audits

- Experience working in a pharmaceutical environment with exposure to manufacturing processes and GMP principles

Benefits:

- Comprehensive benefits program, including onsite cafeteria, gym, and licensed Health & Wellness clinic

- Commitment to inclusion and diversity, positive work environment, and opportunities for career growth

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## Skills

### Required
- GxP Regulations
- Pharmaceutical Regulatory Compliance
- Quality Assurance (QA)
- Risk Awareness
- Technical Writing
- Data Integrity
- Detail-Oriented
- Digital Fluency
- Influencing Without Authority
- Lean Management
- Problem Solving

### Nice to have
- Microsoft Office
- MERP
- LIMS
- cGMP - FDA
- continuous improvement tools
- IT applications

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Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---North-Carolina---Zebulon/Senior-Batch-Record-Review-Specialist--Nights-_450903?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)