Team Leader, Cuvettes - San Diego

Werfen•San Diego, CA

About The Position

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: 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.

Requirements

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.
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.

Nice To Haves

Previous lead experience preferred.
Working knowledge of Microsoft Office and large Enterprise Resources Planning (ERP) system preferred.

Responsibilities

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.