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Manufacturing Technologist

The Manufacturing Technologist will be directly involved in the manufacturing of in vitro diagnostics kits under a GMP/QSR regulated manufacturing environment. Manufacturing tasks include the execution of routine protocols and instructions, monitoring of critical process steps, as well as drafting and revision of various manufacturing documents (e.g., batch records, SOPs, forms, technical reports). In addition, the Manufacturing Technologist will prepare reagents, formulate, fill and package final product components.

Job description
  • Execute and monitor manufacturing process steps in accordance with written instructions (e.g Device Master Records, SOPs, Work instructions)
  • Operate and maintain production equipment in a clean room environment within established specifications
  • Maintain manufacturing rooms in a proper state of cleanliness in accordance with written SOP's
  • Prepare batch documentation and SOPs according to GMP principles and internal standards
  • Review process and equipment documents
  • Ensure timely completion and review of all manufacturing records
  • Track components to ensure traceability of intermediates, products and raw material inventory
  • Initiate non-conformance reports by accurately describing non-conformance, identify and segregate non-conforming material
  • Participate in quality and customer complaint investigations
  • Assist in the implementation of new equipment into Manufacturing
  • Participate in process improvement initiatives and transferring new products into Manufacturing
  • Participate in internal and external audits
  • Comply with the company’s Quality Management System, corporate policies, regulatory and health and safety requirements
  • Other related duties as assigned


  • At least 2 years of experience working in a GMP/QSR environment
  • Working knowledge of microarray production equipment
  • Computer literate, proficient with Microsoft Office applications
  • Highly motivated, conscientious, self-managed team player with experience working in a production team environment
  • Proven technical competency
  • Strong problem solving skills
  • Strong communication skills, both verbal and written
  • Attention to detail.


Please send your résumé and cover letter to, with the job title in the subject line.