Change Systems Analyst/Supervisor

Introduction

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

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.

Responsibilities

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, 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 the following SAP tools: EVP (Electronic Validation Protocol) Tool and Template, APG (Auto Part Number Generator) Tool and Configuration, AML (Approved MFG List) upload tool, MIS (Material Input Sheet) 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.

Budget Managed (if applicable):

• N/A

Internal Networking/Key Relationships:

• To be determined based on department needs

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
• Functional/Technical Skills: Excellent SAP, MS Office, Adobe Acrobat
• Continuous Improvement/ Root Cause Analysis (LSS)

Qualifications

Min Knowledge & Experience required for the position:

• Bachelor's Degree or equivalent.
• Minimum of 8 years of specific experience with a proven background 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

International Mobility:

• Required: no

Travel Requirements:

• <5>

The annual base salary range for this role is currently $100,000.00 to $130,000.00. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

Closing

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [email protected] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com