Team Leader, Cuvettes - San Diego

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:

The Cuvettes Team Leader supports daily production and inventory management ensuring quality, production, efficiency, and timely delivery of existing and new/modified products to stock.  As directed, the Cuvettes Team Leader also leads department staff in assigned daily tasks in support of manufacturing activities.

Responsibilities

Key Accountabilities

Essential Functions:

• Execute assigned weekly production plan as per weekly schedule; operate a variety of manufacturing equipment as necessary 
• Support daily production and packaging activities in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs).
• Continually work to achieve assigned production goals; meet unscheduled peaks in workload as necessary to ensure timely release of product and to avoid back orders. 
• Oversee inventory to ensure quality, production, and efficiency. 
• Support business and staffing need to achieve effective manufacturing and control of products in compliance with all established manufacturing specifications and control procedures; assist with staff rotation, break scheduling, and shift transfer. 
• Lead department training activities; maintain compliant training records. 
• Ensure safe working conditions throughout the department at all times; adhere to all safety policies and procedures and support safety training and inanities. 
• Ensure support for the transfer of technology (product) to routine manufacturing; evaluate new technologies and the pilot work that is required to assure minimum problems with initial and subsequent manufacturing. 
• Support special projects as assigned by management. 
• Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs. 
• Identify production and manufacturing issues and work to implement corrective action. 
• Work cross-functionally to coordinate corrective action for technical problems related to raw materials, finished products; minimize rejects and field complaints. 
• Ensure and maintain compliance with the Companys quality system requirements through training and adherence to policies, procedures and processes. 
• Other duties as assigned.

Qualifications

Minimum Knowledge & Experience Required for the Position:

• High school diploma or equivalent; additional training/education a plus. 
• Three (3) to five (5) years previous related manufacturing experience within a regulated medical device manufacturing or pharmaceutical environment. 
• Previous lead experience preferred. 
• Understanding of coagulation-based manufacturing processes and company products. 
• Familiarity with GDP, GMP, Good Laboratory Practices (GLP), FDA, and ISO. 
• Working knowledge of Microsoft Office and large Enterprise Resources Planning (ERP) system preferred. 
• Good written and verbal communication. 
• Ability to work as part of a team. 
• Ability to identify and correct problems.

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

Werfen appreciates and values diversity.  We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.

We operate directly in over 30 countries, and in more than 100 territories through distributors.  Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com