Team Leader, Cuvettes - San Diego at Werfen GmbH

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

04 May, 26

Salary

31.0

Posted On

03 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Production Planning, Inventory Management, Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), Staff Scheduling, Training, Safety Compliance, Technology Transfer, Corrective Action, Quality System Compliance, Good Documentation Practices (GDP), Medical Device Manufacturing, Coagulation-based Manufacturing, FDA Compliance, ISO Compliance

Industry

Medical Equipment Manufacturing

Description

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: 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. The pay range for this role is $28-$31/hr, depending on experience. 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. Closing If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. 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 NAtalentacquisition@werfen.com 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. www.werfen.com

Responsibilities

The Team Leader supports daily production and inventory management, ensuring quality, efficiency, and timely delivery of existing and new products according to the weekly schedule and GMP standards. This role also involves leading department staff in assigned daily manufacturing tasks, overseeing inventory, and ensuring safety and compliance.