Document Control Specialist

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.

Position Summary:

Responsible for prioritizing and coordinating Change Order submissions. Acts as an interface between all functions to ensure the appropriate changes are properly documented and implemented for change order submission and general documentation guidance. The Document Control Specialist I implements changes to change orders including; documentation, Bill of Materials, drawings, routings, material masters, etc.

Key Accountabilities:

• Reviews change order submissions for completeness, accuracy, reference compliance and process accordingly.
• Identifies gaps in the change order process and makes recommendations for solutions.
• Assists in the Quality Manual structure and may provide guidance when necessary.
• Assists in processing of the Approved Manufacturers List (AML), ensuring the list is updated and approved.
• Processes submissions for Validation Protocols (VP) and conclusions and implements the final VPs.
• Works cross functionally with the Change Order Implementers to evaluate impact to Bill of Materials (BOM), revisions, linked and reference documents, etc.
• Assists with the Restrictions on Hazardous Specifications (ROHS) project to guide and screen for all requests.
• Customer support by facilitating and assisting customers with Change Order creation, planning and implementation.
• Track expired protocols and address with protocol owners.
• Provides assistance with technical aspects of Change Orders, including material disposition, field properties.
• Ensures that existing Change Order procedures and Documentation Standards are followed and adhered to.
• Manages software submissions.
• Creates SAP BOM's for assemblies, Printed Circuit Boards with reference designator and BOM allocation.
• Processes change orders from the multi-plant and cross plan work flow

Budget managed (if applicable) N/A

Internal Networking/Key Relationships

• To be determined based on department needs

Skills & Capabilities:

• Oral and Written Communications, Action Oriented;
  Organization, Team Work

The annual salary range Werfen reasonably expects to pay for the position is $65,000 to $85,000. Compensation is reasonably based upon multiple factors including education, relevant experience, skillset, knowledge, and specific needs of the business.

Minimum Knowledge & Experience Required for the Position:

• Associates Degree in a business or technical discipline or equivalent.
• Minimum of 1 year of documentation control experience.
• Experience with electronic change control systems and their interface with ERP systems.
• 3 yrs of related experience in Operations, Quality, or R&D areas.
• Solid Written and Verbal Communication Skills.
• Strong knowledge of Microsoft Word, Excel, Visio, and Adobe Acrobat

International Mobility:

Required:

No

Travel Requirements: No

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 N 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.