Operational Quality Specialist

Position Summary You will ensure adherence to cGxP standards and procedures through the independent oversight of GxP processes. The role focuses on preventing and identifying quality issues, maintaining inspection readiness, and acting as a liaison between operations and the QA Departments. The position is on‑site at a U.S. manufacturing site and requires regular presence in production and laboratory areas. Responsibilities Ensure GMP processes and operational personnel adhere to current GMP, applicable regulatory requirements, and procedures. Maintain shopfloor oversight, serve as the first line of contact for quality issue management, and provide timely quality escalations. Provide guidance during GMP activities to proactively detect potential quality issues through active real‑time observation. Perform spot‑checks of production, testing, cleaning, and maintenance activities to ensure compliance with quality standards. Review cGMP documentation and records, ensuring compliance with GDP and ALCOA+ principles for data integrity. Review and final approve batch records and associated documentation. Review, initial impact approve, and final approve deviations and associated CAPA plans. Review and approve changes to procedures, logbooks, PQRs, customer complaint investigations, change controls, validation documents, and other quality documentation. Ensure all GMPs, validations, quality, safety, and environmental regulations are met. Adhere to all GSK safety guidelines and procedures. Role model GPS standards and foster a ‘Quality Starts with Me’ culture through coaching and communication. Basic Qualification Bachelor’s degree in a scientific, engineering, or technical discipline; or an associate degree with a minimum of two years of relevant experience. Minimum of 2 years of experience in a regulated life sciences manufacturing or quality role. Knowledge of GMP and good documentation practices. Experience reviewing batch records and GMP documentation. Preferred Qualification Sound knowledge of pharmaceutical facilities, equipment, and quality systems. Knowledge of GMP, NIH Guidelines, FDA and other regulatory agency compliance requirements. Working knowledge of validation principles, aseptic processing, quality systems, and FDA regulations. Training and experience in DMAIC root cause analysis methodology. Well‑developed interpersonal skills and decision‐making capabilities with the ability to influence across the site and quality organization. Strong written and verbal communication skills and the ability to coach and foster continuous improvement. Time‑management skills and ability to prioritize and respond to operational needs in a high‑paced environment. Team player prepared to work in a multi‑skilled, team‑based culture. Equal Employment Opportunity GSK is an Equal Opportunity Employer. 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 other basis prohibited under federal, state, or local law. #J-18808-Ljbffr