Hiring: Operational Quality Specialist - MES Company: GSK Location: Marietta, PA Job Posted Time: 2026-09-16 13:52:14 Target Skills & Keywords : AI, Manufacturing Execution Systems, Quality Assurance, Regulatory Compliance, Root Cause Analysis, SAP About the job Experience: •3 years' experience in regulated industry preferably in Quality Assurance. •Minimum 3 years' experience in regulated industry preferably in Quality Assurance. Required Skills: •Provide operational QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps. •Ensure that all GMP processes and operational personnel adhere to current GMP, validation, quality, safety and environmental regulations are met maintaining inspection readiness at all times. •Review eCC, TCD and/or other QS change for impact to: Master Data (Equipment, sMBR, Workstations, Workcenters). Main-PI, Sub-PI design/validation •Equipment Spec File (as QA Master Data) sMBR (as sMBR QA Reviewer) including integration with SAP and OsiPi •Review and approve creation and/or updates to URS and Design of Main-PI, Sub-PI (as QA PI Reviewer and QA Ops, as applicable) Including integration with SAP and OsiPi •Approval of Validation Form for Main-PI, Sub-PI pre and post-execution (as QA PI Reviewer) including applicable incident management and including integration with SAP and OsiPi •GxP, DI, Business Continuity Risk Assessments, PI inventory •IO/PQ protocol and report, including applicable validation impact assessment/unplanned events (as QA PI Reviewer and QA Ops, as applicable). Audit Trail Reviews Qualifications: •Bachelor’s degree in Life Sciences, Biology, Chemical Engineering. A bachelor's degree in other disciplines may be acceptable if sufficient technical depth has been achieved from experience. •Requires understanding and experience with pharmaceutical facility, equipment and systems. Including technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities. •Training and work experience in DMAIC root cause analysis methodology. •Operational familiarity with electronic records guidance such as 21 CFR Part 11 or Annex 11. •Hands-on experience supporting system validation (IQ/OQ/PQ) or computerized system lifecycle tasks. •Well-developed interpersonal skills and decision-making capabilities with the ability to influence different levels of the Site and Quality organization. Ability to deliver clear communications (written and verbally), coaching, foster a ‘Quality Starts with Me’ culture and work with a spirit of continuous improvement. •Demonstrated capacity to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal quality solutions and implement decisions. •Time management skills and ability to prioritize and respond to operational needs/issues within high paced environment. •Training or experience in root cause analysis and CAPA methodologies. Demonstrated ability to influence cross-functional teams and coach colleagues on quality and data practices. Compensation: •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!