Quality Systems eQMS Specialist

Scientific Protein Laboratories LLC; California; Hybrid; USD 110,000 - 160,000; Full time

Job summary

Scientific Protein Laboratories LLC seeks an experienced Quality Systems eQMS Specialist to join our Quality Assurance organization. The role focuses on configuring, validating, and maintaining the electronic Quality Management System and Electronic Batch Records in a regulated cGMP environment.

You will collaborate with Manufacturing, Quality, and IT to ensure data integrity, lifecycle management, and compliant workflows, while supporting audits and training initiatives across the site.

Job description

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**:* 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.* 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.* 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.* 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.* 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.* 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**: