Manufacturing Associate I - ELISA Controls

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.

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.

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

Minimum Knowledge & Experience

Education: Bachelor's degree in biological or related sciences required. Certificate program or A.S. degree with 3-4 years relevant experience in a life sciences laboratory may be substituted 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.

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.