Associate Manufacturing Scientist(Engineer)
SQI Diagnostics
Toronto,Ontario,Canada
13d ago

Upper

The Associate Manufacturing Scientist (Engineer) 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 in the afternoon shift, 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 Associate Manufacturing Scientist has the opportunity to rotate amongst groups and be exposed to R&D, Quality and Operations at SQI as we grow.

Responsibilities :

  • 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 SOPs
  • 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, identifying, and segregating 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 transfer of 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 duties as assigned
  • Education, Qualifications and Requirements :

  • Post-secondary degree, preferably in a biological science or engineering
  • Working knowledge of microarray production equipment highly desirable
  • Computer literate; proficient with Microsoft Office applications
  • Protein chemistry knowledge and asset
  • Highly motivated, conscientious, self-managed team player with experience working in a production team environment
  • Programming skills is an asset
  • Other Required Skills :

  • Ability to work independently without supervision
  • Flexibility in schedule as needed; Core shift will be 12-8, flexibility required to meet the needs of the business
  • Strong problem solving skills
  • Strong communication skills, both verbal and written
  • Attention to details
  • Apply
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