Senior Batch Record Review Specialist

GSK•Zebulon, NC

3d•Onsite

About The Position

This role will lead batch record review activities to release product that is manufactured and/or packaged in compliance with regulatory agencies’ requirements and company standards. The position will also provide quality guidance to the 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 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.

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.

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