Quality Systems eQMS Specialist

Quality Systems eQMS Specialist

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 E  responsibilities and provide reliable, compliant quality system support across the organization.

Responsibilities include:

• eQMS & E  Configuration and Administration
• 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.
• E  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 E  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 E  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 E  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.

Job Requirements and

Qualifications:

Education:

Associate degree or equivalent work experience required;
Bachelor's degree and system administration of an electronic quality management system experience preferred

Experience:

2 plus years required; 5 plus years preferred

WHY JOIN SPL?

Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.

Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1;
Life and AD&D Insurance, and Short and Long-term Disability;
Health and Flexible Saving Account options;
Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!

SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.