eQMS Quality Systems Specialist – EBR & Compliance

Scientific Protein Laboratories; Waunakee (WI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive compensation

Excellent benefits package

401(k)

Paid holidays

Career advancement opportunities

Job summary

Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, is seeking a Quality Systems eQMS Specialist in Waunakee, WI. This role integrates with QA to administer the electronic Quality Management System and Electronic Batch Records, ensuring data integrity and regulatory compliance.

You will configure modules, support EBR lifecycles, develop dashboards, and drive continuous improvement while maintaining 21 CFR Part 11 and EU Annex 11 compliance in a cGMP environment.

Qualifications

• Associate degree or equivalent work experience required;Bachelor’s degree and system administration of an electronic quality management system experience preferred.
• 2+ years of experience in a regulated quality management or eQMS environment;5+ years preferred.

Responsibilities

• Configure, maintain, and support eQMS modules (Document Control, Change Management, Training, Audit Management, Quality Events, EBR).
• Support creation, configuration, validation, release, and maintenance of Electronic Batch Records (EBRs).
• Develop and support system integrations and data exchanges via eQMS API toolkit.
• Develop, maintain, and optimize dashboards and reports using eQMS analytics.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, data integrity.

Education

Associate degree or equivalent

Bachelor’s degree

Job description

Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, is seeking a Quality Systems eQMS Specialist in Waunakee, WI. This role integrates with QA to administer the electronic Quality Management System and Electronic Batch Records, ensuring data integrity and regulatory compliance.

You will configure modules, support EBR lifecycles, develop dashboards, and drive continuous improvement while maintaining 21 CFR Part 11 and EU Annex 11 compliance in a cGMP environment.