Senior Quality Systems Specialist I

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:

Responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS.  The focus of the position is to assist in maintaining and monitoring key Quality Systems.  Duties may include CAPA, Internal Audits, Supplier Audits, Affiliate Audits, External Documents, Management Review, Procedure development, key metric reporting and other key project support under the supervision of the Quality Systems Manager.

 

This position is located out of our Bedford, MA facilities and the anticipated work set up is 4 days onsite and 1 day remote.

Responsibilities

Key Accountabilities

Essential Functions:

• The Senior Quality Systems Specialist I will be expected to support all activities within the Quality Systems team shown below but will have primary responsibility for maintenance and improvement of at least one of the following:
  • CAPA process – tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities, ensuring root cause analysis, actions, verification of effectiveness are appropriate
  • Internal Audit program – planning, conducting, reporting, and transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure of the audit.
  • Quality Agreements – maintaining up-to-date files, updating agreements to current template, communicating with affiliates and/or distributors regarding status under minimal supervision
  • Quality Plans – issuing number, creating plan, tracking status, timely/appropriate closure
  • External Documents – tracking, trending of the External Document process. Driving timely/appropriate initiation and completion of Action Plans.
  • Management Review – Support the creation and delivery of the Management Review presentation. Support completion and approval of the Management Review Meeting Minutes and closure of Action Items.
  • Training program – focusing on improving the competencies of personnel to ensure compliance with regulatory requirements and written procedures by creating and maintaining training materials and delivering training as needed.

 

Secondary Functions:

• Facilitates meetings related to QS activities
• Supports change orders/process improvements with respect to Quality Management System procedures with direction from management
• Assist with development and maintenance of a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs
• Participates in internal, external (including regulatory) and/or 3rd party audits, as needed
• Carries out duties in compliance with established business policies
• Provides assistance and recommendations based on a clear understanding and implementation of regulatory standards
• Interfaces with all functions and levels of management as needed
• Other duties as assigned, according to the changing needs of the business

 

Networking/Key relationships

To be determined based on department needs, to include interactions such as:

• All IL Departments
• Werfen Affiliate QARA
• Werfen Corporate and other Werfen Manufacturer QARA

 

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and capabilities:

• Attention to Detail: Good ability to pay close attention to detail is required
• Accuracy: Work is accurate and completeness of records