Quality Control Specialist - MES Job Marietta Pennsylvania USA,Quality Assurance

Location: Marietta

Business Introduction: We manufacture and supply reliable, high‑quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations;

it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

Position Summary: To ensure adherence to cGxP standards and procedures through the independent oversight of GxP processes. To improve the effectiveness of quality in preventing /identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. Directly support Operational through development, review, and approval of MES related design, implementation and performance management tasks. You will provide operational quality assurance for Manufacturing Execution System activities that support drug product manufacturing.

You will work closely with manufacturing, engineering, IT, and quality teams to keep processes compliant and data trustworthy. We value clear decision makers who coach others and act with integrity. This role offers hands‑on learning, visible impact, and clear career growth aligned with our mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities:

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, sM , Workstations, Work centers). Main-PI, Sub-PI design/validation
Review and approve creation and/or updates to master data:
Equipment Spec File (as QA Master Data) sM (as sM QA Reviewer) including integration with SAP and Osi Pi
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 Osi Pi
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 Osi Pi
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
Develop/Approve MES LSOPs and associated child documents
Provide review, initial impact approval, and final approval of devations and associated CAPA plans, logbooks, PQRs, customer complaint investigations, change controls, validation documents, etc.
Role model the GPS standards and foster a ‘Quality Starts With Me’ culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non‑compliance can have on product quality and patient safety.
Perform regular shopfloor and system walkthroughs to identify risks and coach teams on good documentation and data integrity.
Lead or support investigations for deviations, system incidents, and data…