Manufacturing Associate 1 - ELISA Controls

Introduction

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

Job Summary

Join Werfen's Autoimmunity business as a Manufacturing Associate I and play a key role in producing diagnostic products that help clinicians around the world detect autoimmune disorders. As a Manufacturing Associate within our ELISA controls team, you'll operate and maintain specialized manufacturing equipment, support the production of ELISA controls, monitor quality throughout the process, and ensure products are stored and handled according to established procedures. You'll spend your day setting up equipment, overseeing production runs, inspecting materials, documenting work, and contributing ideas that improve efficiency and quality. Working alongside a supportive and collaborative team, you'll have the opportunity to develop expertise in regulated manufacturing environments while building skills in troubleshooting, equipment validation, and continuous improvement, creating a strong foundation for long-term career growth within Werfen.

Responsibilities

Key Accountabilities

• Under supervision follows standard operating procedures, work instructions, and other procedures for routine manufacturing and/or testing.
• Participates in the bulking and/or evaluation of in-process components and reagents according 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 testing.

• 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.

Networking/Key relationships

• Other Manufacturing teams
• Operations teams, including Equipment Engineering, Facilities & Environmental Health & Safety (EHS)
• Shared Services teams, including Filling and Packaging
• Product Testing team
• Manufacturing Technical Service
• Global Systems Support

Qualifications

Minimum Knowledge & Experience for the position

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 to continuous learning.

Compensation

The annual base hourly pay range for this role is currently $23 to $29/hr. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

Travel requirements No routine travel required

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 [email protected] 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