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 Technical Operator I utilizes an array of production equipment as well as manual assembly to manufacture and package cuvette products. The Cuvettes Technical Operator I is also responsible for an array of other manufacturing related tasks.

Key Accountabilities

Essential Functions:

• 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.
• Work with Team Leader and Supervisor to detail critical raw materials, in-process procedures, and specifications.
• Support corrective action for technical problems related to raw materials, finished products; minimize rejects and field complaints.
• Perform in-process quality checks on sub-assemblies and finish products.
• Identify line issues and other production problems; promptly notify Team Leader or Supervisor of required corrective action.
• Support all efforts and procedures to maintain optimal manufacturing conditions.
• Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs.
• Maintain safe working conditions at all times; adhere to all safety policies and procedures.
• Use computerized Materials Resource Planning (MRP) inventory system as required to report lot controlled ingredients on batch records.
• As needed, and as directed, support with formulation activities.
• Operate production equipment as directed and in accordance with all SOPs.
• Ensure production areas are continually kept clean.
• Prevent mix-up of products, materials, labels, and other components.
• As directed, provide support for process and equipment validation.
• Maintain daily product log books as directed.
• As necessary, and as directed assist with formulation preparations.
• Ensure and maintain compliance with the Companys quality system requirements through training and adherence to policies, procedures and processes.
• Other duties as assigned.

Minimum Knowledge & Experience Required for the Position:

• High school diploma or equivalent.
• At least two (2) years previous assembly/packaging experience; previous experience in a regulated medical device manufacturing or pharmaceutical environment strongly preferred.
• Previous experience with, or ability to, quickly comprehend coagulation-based manufacturing processes.
• Familiarity with GDP, GMP, Good Laboratory Practices (GLP), FDA, and ISO.
• Knowledge of qualification and validation trials a plus.
• 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.

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