Manufacturing Associate 1

Werfen-posted 1 day ago
$25 - $30/Yr
Full-time • Entry Level
San Diego, CA
5,001-10,000 employees
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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 QUANTA Flash and Aptiva team manufacture coupled beads, calibrators, controls, and all other related components.

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
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