Manufacturing Technologist II with testing responsibility

I. Position Description

• Manufacturing Technologist II personnel participate in all activities related to the manufacturing of Hemo bioscience products as well as process evaluation. This position is responsible for following standard operating procedures, best laboratory practices, current good manufacturing practices (cGMP) and current good documentation practices (cGDP) to ensure products are manufactured and systems are maintained to meet internal and customer specifications. 

II. Major Areas of Responsibility

• Manufacturing Laboratory, technical and analytical  

III. Specific Responsibilities of the Job Include the following.  Other duties may be assigned, as needed.

• Adheres to manufacturing schedule to ensure products are prepared and released to inventory to meet shipping deadlines.
• Follows SOPs, best laboratory practices, current good manufacturing practices and current good documentation practices to ensure products are manufactured to meet specifications.
• Participates in all technical and non-technical aspects of the manufacturing process from receipt of raw material to release of finished product.
• Activities include, but are not limited to:
  • Customer label approval
  • Product label generation and printing
  • Product filling and capping
  • Lab inventory and cleaning
  • Temperature monitoring of refrigerated systems
  • Equipment maintenance
  • Specimen processing
  • Solutions preparation
  • Raw material qualification
  • Equipment IQ/OQ/PQ
  • Product Manufacturing
  • Product Testing (In-Process & Bulk QC)
  • DHR Creation & Maintenance
  • Maintenance of updates to manufacturing SOPs through document control processes o Process Deviation Write-ups
• Responsible for documentation of all manufacturing related activities
• Provides suggestions for better production and staff performance