About this opportunity
Paycom - ATS lists this eQMS Technical Manager opportunity in waunakee, Wisconsin. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Job Details: Job Location: Scientific Protein Laboratories - Waunakee, WI 53597, 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). S
The eQMS Technical Manager 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 Technical Manager is expected to quickly assume full ownership of assigned eQMS and EBR responsibilities and provide reliable, compliant quality system support across the organization.
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.
Requirements
Education: Associate degree or equivalent work experience required; system administration of an electronic quality management system experience
Bachelor’s degree and system administration of an electronic quality management system experience preferred
Experience: History of providing reliable eQMS systems for a regulated cGMP organization aligned with ALCOA+ principles
Experience ensuring data integrity
Experience configuring, maintaining and supporting eQMS Modules
Experience designing and maintaining electronic workflows, approval routing, access
Supported creation, configuration validation, release and maintenance of EBR’s (Electronic Batch Records)
History of partnership with Manufacturing, IT to ensure EBR’s are aligned all approvals and records, processes and regulatory expectations
Create and optimize dashboards and reports using eQMS analytics
Support end user training
Participate in internal audits, regulatory inspections and customer audits
Prepare audit documentation, respond to inquiries and lead remediation of system-related findings
WHY JOIN SPL?
Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.
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.
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Worksite address
waunakee, WI, 53597, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.