Senior Batch Record Review Specialist

GSK•Zebulon, NC

11d•Onsite

About The Position

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. 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.

Requirements

High School Diploma plus 4 years relevant experience in the pharmaceutical industry, with a production or quality background. -or- Associates degree plus 2 years relevant experience in the pharmaceutical
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.

Nice To Haves

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.
Entry level experience of MERP.

Responsibilities

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.