What are the responsibilities and job description for the Quality Systems eQMS Specialist position at Scientific Protein Laboratories?
Job Summary
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:
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eQMS & EBR Configuration and Administration
EBR Lifecycle Support
System Integration & Data Management
Reporting, Metrics & Continuous Improvement
Validation & Regulatory Compliance
User Support & Troubleshooting
Training & Change Management
Audit & Inspection Support
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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.