Senior Batch Record Review Specialist
GSK
June 26, 2026
On-site
Zebulon, NC
Operations
Position Summary:
Lead batch record review activities to release product manufactured and/or packaged in compliance with regulatory requirements and company standards. Provide quality guidance to the Production department.
Responsibilities:
- Review, release, and second check batch record documentation for compliance to cGMPs, SOPs, and internal/regulatory requirements.
- Coordinate investigations for production deviations as needed; close Planned Notifications as needed.
- Assist with NRFT issues for batch documents.
- Provide quality guidance to production operations; complete work order assessments and atypical comments.
- Communicate with team members; escalate issues to production and Quality; provide on-call support as needed.
- Support self-inspections, internal audits, and regulatory inspections.
- Support Problem Solving/Root Cause Analysis and appropriate CAPAs; support OQ training.
- Support GMP documentation corrections.
- Support continuous improvement.
- Support certificate (CoA/CoC) creation, review, and second check verification.
- Agree personal objectives from the quality strategy and develop oneself.
Basic Qualifications:
- High School Diploma + 4 years relevant pharmaceutical industry experience (production/quality) OR Associate degree + 2 years relevant experience.
- BS/BA with 2 years relevant pharmaceutical industry experience.
- 3+ years’ experience in batch record review, QA, or operations in a regulated life sciences environment.
- Practical knowledge of GMP and GDP.
- Experience reviewing production, laboratory, and control records for compliance.
- Experience with quality systems (deviations, CAPA, change control, lot release).
Preferred Qualifications:
- Bachelor’s in scientific/engineering/quality discipline.
- Knowledge of cGMP and FDA/other regulatory requirements.
- Continuous improvement tools; IT applications (e.g., MERP, Microsoft Office, LIMS).
- Good communication/organization; attention to detail; follows procedures.
- Commitment to accuracy, integrity, and quality; able to work independently and as a team player.
Work arrangement:
- On-site; may require some nights or weekend work (shift premium eligible).
Application instructions:
- Please apply and tell how your experience fits the role.
Lead batch record review activities to release product manufactured and/or packaged in compliance with regulatory requirements and company standards. Provide quality guidance to the Production department.
Responsibilities:
- Review, release, and second check batch record documentation for compliance to cGMPs, SOPs, and internal/regulatory requirements.
- Coordinate investigations for production deviations as needed; close Planned Notifications as needed.
- Assist with NRFT issues for batch documents.
- Provide quality guidance to production operations; complete work order assessments and atypical comments.
- Communicate with team members; escalate issues to production and Quality; provide on-call support as needed.
- Support self-inspections, internal audits, and regulatory inspections.
- Support Problem Solving/Root Cause Analysis and appropriate CAPAs; support OQ training.
- Support GMP documentation corrections.
- Support continuous improvement.
- Support certificate (CoA/CoC) creation, review, and second check verification.
- Agree personal objectives from the quality strategy and develop oneself.
Basic Qualifications:
- High School Diploma + 4 years relevant pharmaceutical industry experience (production/quality) OR Associate degree + 2 years relevant experience.
- BS/BA with 2 years relevant pharmaceutical industry experience.
- 3+ years’ experience in batch record review, QA, or operations in a regulated life sciences environment.
- Practical knowledge of GMP and GDP.
- Experience reviewing production, laboratory, and control records for compliance.
- Experience with quality systems (deviations, CAPA, change control, lot release).
Preferred Qualifications:
- Bachelor’s in scientific/engineering/quality discipline.
- Knowledge of cGMP and FDA/other regulatory requirements.
- Continuous improvement tools; IT applications (e.g., MERP, Microsoft Office, LIMS).
- Good communication/organization; attention to detail; follows procedures.
- Commitment to accuracy, integrity, and quality; able to work independently and as a team player.
Work arrangement:
- On-site; may require some nights or weekend work (shift premium eligible).
Application instructions:
- Please apply and tell how your experience fits the role.