Lead Site Investigation Specialist - GMP & CAPA

Associate Site Investigation Specialist job at GSK. King of Prussia, PA. Site Name: USA - Pennsylvania - King of Prussia Posted Date: Sep 16 2025 Overview We make and supply medicines and vaccines all around the globe. Our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021. We are modernizing to launch more products at speed while turbo‑charging delivery across our portfolio through a relentless focus on quality, safety, and service. Our R&D pipeline demands a new kind of supply chain, and we need the best minds to help us make more complex products with automation and robotics. Responsibilities Serve as the Lead Investigator for deviations, utilizing standardized processes from the GSK Orange Belt Training and Certification program. Apply DMAIC problem‑solving and GSK Production System (GPS) tools to improve efficiency, eliminate waste, and prevent non‑compliance events. Conduct thorough and timely investigations of deviations, non‑conformances, and other quality events, ensuring all relevant information is collected and analyzed. Use appropriate problem‑solving tools and techniques to identify root causes and implement effective corrective and preventive actions (CAPAs). Collaborate with cross‑functional teams such as production, quality assurance, quality control, engineering, labs, and warehouse to gather information and support CAPA implementation. Prepare comprehensive investigation reports documenting findings, root causes, and CAPAs with accuracy and compliance to regulatory and internal standards. Serve as an expert in the Validated Quality Management System (VQMS) for tracking, managing, and documenting investigations, while providing training and support for effective system utilization. Deliver training and guidance to personnel on investigation processes, root cause analysis techniques, and deviation management to foster a quality‑focused culture. Adhere to ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) for all documentation tasks. Own deviation and environmental monitoring investigations, write‑ups, corrective and preventive action management, impact assessments, and simple change controls. Why you? You will lead key activities that progress your career and are integral to ensuring product quality, patient safety, regulatory compliance, and the facility’s License to Operate. Basic Qualifications Bachelor’s degree. 1+ years of GMP processing and/or industry‑related experience, exhibiting a skill set of supporting all aspects of production processing and demonstrating technical competency. Preferred Qualifications Bachelor’s of Science. Familiar with cGMPs, regulatory guidelines, governmental codes, and standard operating procedures. Orange Belt Certification. GSK is an Equal Opportunity Employer. We do not discriminate against protected classes. 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. #J-18808-Ljbffr GSK