Quality Systems eQMS Specialist

Scientific Protein Laboratories•Waunakee, WI

12d•Onsite

About The Position

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Quality Systems eQMS Specialist. The Quality Systems eQMS Specialist will be integrated into the Quality Assurance organization and will support all core Quality System functions through the administration, configuration, validation, and continuous improvement of the electronic Quality Management System (eQMS), including Electronic Batch Records (EBRs). The individual is expected to possess prior experience in a regulated cGMP environment and demonstrate the ability to rapidly achieve independent operational capability. With appropriate onboarding and management guidance, the Specialist is expected to quickly assume full ownership of assigned eQMS and EBR responsibilities and provide reliable, compliant quality system support across the organization. Responsibilities include: eQMS & EBR Configuration and Administration Configure, maintain, and support eQMS modules, including Document Control, Change Management, Training, Audit Management, Quality Events (Deviations, CAPA, Complaints), and Electronic Batch Records (EBRs). Design and maintain compliant electronic workflows, approval routing, and controlled access based on defined roles and responsibilities. Ensure data integrity, traceability, and lifecycle management of records in alignment with ALCOA+ principles. EBR Lifecycle Support Support creation, configuration, validation, release, and maintenance of Electronic Batch Records. Partner with Manufacturing, Quality, and IT to ensure EBRs are aligned with approved master batch records, process requirements, and regulatory expectations. Support EBR review processes, exception handling, and batch release activities. System Integration & Data Management Develop and support system integrations and data exchanges using the eQMS API toolkit and related interfaces. Ensure secure data transfer, version control, and audit trail functionality across integrated systems. Reporting, Metrics & Continuous Improvement Develop, maintain, and optimize dashboards and reports using eQMS analytics and insights tools. Support business process monitoring, trending, and management review through meaningful quality metrics. Maintain access controls and user role management (Author, Reviewer, Approver, Viewer) in compliance with segregation-of-duties principles. Validation & Regulatory Compliance Execute computer system validation (CSV) and periodic review activities in accordance with internal procedures and regulatory requirements. Support eQMS and EBR release cycles using validation accelerators and risk-based validation approaches. Ensure ongoing compliance with 21 CFR Part 11, EU Annex 11, data integrity, and applicable global regulatory expectations. User Support & Troubleshooting Serve as primary point of contact for system troubleshooting, issue investigation, and root cause analysis related to eQMS and EBR functionality. Coordinate corrective and preventive actions for system-related deviations or audit observations. Training & Change Management Support end-user training, onboarding, and change management initiatives. Develop training materials, user guides, and knowledge articles to promote consistent and compliant system use. Support global rollout, adoption, and continuous improvement of eQMS solutions. Audit & Inspection Support Actively participate in internal audits, regulatory inspections, and customer audits related to quality systems, computerized systems, and EBRs. Prepare audit documentation, respond to audit inquiries, and lead remediation of system-related findings.

Requirements

Associate degree or equivalent work experience required
2 plus years required
cGMP experience

Nice To Haves

Bachelor’s degree and system administration of an electronic quality management system experience preferred
5 plus years preferred

Responsibilities

eQMS & EBR Configuration and Administration Configure, maintain, and support eQMS modules, including Document Control, Change Management, Training, Audit Management, Quality Events (Deviations, CAPA, Complaints), and Electronic Batch Records (EBRs).
Design and maintain compliant electronic workflows, approval routing, and controlled access based on defined roles and responsibilities.
Ensure data integrity, traceability, and lifecycle management of records in alignment with ALCOA+ principles.
EBR Lifecycle Support Support creation, configuration, validation, release, and maintenance of Electronic Batch Records.
Partner with Manufacturing, Quality, and IT to ensure EBRs are aligned with approved master batch records, process requirements, and regulatory expectations.
Support EBR review processes, exception handling, and batch release activities.
System Integration & Data Management Develop and support system integrations and data exchanges using the eQMS API toolkit and related interfaces.
Ensure secure data transfer, version control, and audit trail functionality across integrated systems.
Reporting, Metrics & Continuous Improvement Develop, maintain, and optimize dashboards and reports using eQMS analytics and insights tools.
Support business process monitoring, trending, and management review through meaningful quality metrics.
Maintain access controls and user role management (Author, Reviewer, Approver, Viewer) in compliance with segregation-of-duties principles.
Validation & Regulatory Compliance Execute computer system validation (CSV) and periodic review activities in accordance with internal procedures and regulatory requirements.
Support eQMS and EBR release cycles using validation accelerators and risk-based validation approaches.
Ensure ongoing compliance with 21 CFR Part 11, EU Annex 11, data integrity, and applicable global regulatory expectations.
User Support & Troubleshooting Serve as primary point of contact for system troubleshooting, issue investigation, and root cause analysis related to eQMS and EBR functionality.
Coordinate corrective and preventive actions for system-related deviations or audit observations.
Training & Change Management Support end-user training, onboarding, and change management initiatives.
Develop training materials, user guides, and knowledge articles to promote consistent and compliant system use.
Support global rollout, adoption, and continuous improvement of eQMS solutions.
Audit & Inspection Support Actively participate in internal audits, regulatory inspections, and customer audits related to quality systems, computerized systems, and EBRs.
Prepare audit documentation, respond to audit inquiries, and lead remediation of system-related findings.