Manufacturing Associate

Country

United States

Shift

1st

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.

Job Summary

Werfen Autoimmunity Manufacturing Associates play a critical role in the manufacturing and/or testing of a variety of Autoimmune-related diagnostics products. This position is responsible for the manufacture and/or testing of components of diagnostic kits used by clinicians around the world for the diagnosis of autoimmune disorders. Our Manufacturing Associates work in a highly specialized team environment, using advanced automated equipment and instrumentation to manufacture and test in-process components and raw materials.

Employees help ensure product quality by participating in troubleshooting and developing quality improvements within our multiple value streams. Work is performed under department supervision and in accordance with the company’s Quality Management System.

This position will be working in the ELISA team manufacture ELISA plates, calibrators and controls, and all other related components.

Key Accountabilities

• Under supervision follows standard operating procedures, work instructions, and other pro-cedures for routine manufacturing and/or testing.
• Participates in the bulking and/or evaluation of in-process components and reagents ac-cording to procedures.
• Packages, fills, and operates equipment to ensure in-process components are completed (if applicable).
• Maintains detailed Device History Records and/or any other associated documentation for all manufacturing activities.
• Operates and cleans equipment and instrumentation for routine manufacturing and/or test-ing.
• Assists with evaluations of raw materials (if applicable).
• Follows established safety and environmental procedures.
• Maintains lab and work area in a clean and orderly manner.
• Complies with applicable Werfen standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety (EHS), Human Resources and other regulatory and company policies.
• Reflects Werfen Values in the quality of work and in working relationships.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Minimum Knowledge and

Experience:

Education:

Bachelor’s degree in biologicial or related sciences required. Certificate program or A.S. degree with 3-4 years relevant experience in a life sciences laboratory may be substitued for a degree.

Experience:

0-1 years of life sciences laboratory experience required. Experience in a regulated manufacturing environment in the healthcare sector strongly preferred.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities

• Basic understanding of basic laboratory practices and procedures.
• Basic understanding of Good Manufacturing Practices.
• Strong attention to detail and commitment to quality.
• Attentiveness to details to spot flaws in products or problems with equipment to prevent quality issues. Problem-solving ability to troubleshoot and resolve issues.
• Time management skills to meet production goals without compromising quality.
• Ability to work collaboratively in a team environment.
• Curiosity and commitment…