Document Control Specialist I

Overview

Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing.  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.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA.  Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

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.

Responsibilities

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

Qualifications

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