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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.
Job Responsibility:
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
Requirements:
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
0-1 years of life sciences laboratory experience required
Experience in a regulated manufacturing environment in the healthcare sector strongly preferred
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
What we offer:
medical, dental, and vision insurance
401k plan retirement benefits with an employer match