Senior Batch Record Review Specialist

Position Summary

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.

• 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.
• Agrees personal objectives from the quality strategy and develops oneself.

• 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.

• 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.

This position is on-site and may require some nights or weekend work. Shift work on nights or weekends is eligible to receive a shift premium for work during those scheduled hours.

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.