Change Systems Analyst/Supervisor
Werfen GmbH
Summary
The Change Systems Analyst/Supervisor manages activities related to supervising and guiding personnel directly interacting with the change order system and its associated process controls for the Bedford and Orangeburg Document Control Departments. Will take system ownership and management of the SAP ECM Tool and development of future system enhancements. Responsible for maintaining high quality standards of throughput and accuracy within area of control.
Job description
Position Summary
The Change Systems Analyst/Supervisor manages activities related to supervising and guiding personnel directly interacting with the change order system and its associated process controls for the Bedford and Orangeburg Document Control Departments. Will take system ownership and management of the SAP ECM Tool and development of future system enhancements. Responsible for maintaining high quality standards of throughput and accuracy within area of control.
Key Accountabilities
- Manage the change control systems in compliance with GMP, ISO, and FDA regulations.
- Supervises others in the maintenance, processing, release and implementation of the change control systems.
- Responsible for technical review of data accuracy with the release and change mechanisms.
- SAP change order system ownership and management including providing analysis of end user needs and development of enhancements.
- Develop and deploy change order training agendas and related training materials.
- Perform ECM tool and change order process training as needed.
- Provide CO training assistance and oversight for the affiliate sites when requested.
- Collaborate with IS&S in the validation of all ECM tool changes and associated reports.
- Manage and maintain SAP tools including EVP Tool and Template, APG Tool and Configuration, AML upload tool, MIS tool, BOM I Document extraction tool, and Approved MFG data table.
- Assist in the preparation of documentation needed for product release and support.
- Implement policies and procedures where necessary.
- Mentor staff and develop an ongoing atmosphere of continuous improvement with areas of control focused on compliance.
- System administrator for the Doc Control SCR system.
- Work cross-functionally with other departments to develop new document-related processes and evaluate new tools.
- Facilitate open communication flow with cross functional departments in the support of document preparation, release and support.
Skills & Capabilities
- Strong Communications and Organizational Skills capable of multitasking & meeting critical deadlines
- Proficient with Electronic Change Order Controls
- Project Management and Recruitment
- Robust Document Control Disciplines
- Excellent SAP, MS Office, Adobe Acrobat
- Continuous Improvement/Root Cause Analysis (LSS)
Requirements
- Bachelor's Degree or equivalent
- Minimum of 8 years of specific experience with electronic change control systems and their interface with ERP systems
- Minimum 8 years of related experience in Operations, Quality, or R&D areas
- Experience with ISO Quality System and FDA requirements for the Medical Device Industry, SAP, Agile, or Windchill programs
- Experience with MS Excel, MS Word, MS Visio, and Adobe Pro
- Supervisory experience preferred
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Vacation
- Sick Leave
- Performance-Based Bonus
Company overview
Werfen is a global leader in specialized diagnostics, founded in 1966 in Barcelona, Spain as a family-owned innovative company. The company operates as a worldwide leader in specialized diagnostics across five key clinical areas: Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. With headquarters in Barcelona and technology centers in the United States and Europe, Werfen operates directly in 30 countries and serves more than 100 territories through distributors. The company reported worldwide sales of nearly €2.2 billion in 2024 and employs approximately 7,000 people globally. Werfen develops, manufactures, and distributes comprehensive diagnostic systems, reagents, data management solutions, and automation platforms that help healthcare providers enhance hospital efficiency and patient care. Their product portfolio includes industry-leading analyzers for coagulation testing, point-of-care blood gas systems, transfusion compatibility solutions, autoimmune disease diagnostics, and transplant compatibility testing. The company is committed to innovation, quality, and sustainability, with a focus on delivering meaningful innovations that enhance patient care and contribute to healthier societies worldwide.