Position Summary:

This position is primarily responsible for the manufacturing, assembly and shipment of various biomaterial collection kits used for clinical trials. 

Essential functions of the job include but are not limited to:

Kit Manufacturing:

• Prepare Sample Collection Kits per Standard Operating Procedures and Project Operating Procedures
• Assemble and label Kit Components; including collection tubes, vials, documentation, and boxes per specific Assembly Instructions
• Aliquot reagents using Aseptic Technique
• Complete Batch Records and supporting documentation
• Report discrepancies to Supervisor or Manager

Receive Supplies into Kit Production Inventory: 

• Receive and inspect purchased product
• Quarantine and prepare Raw Materials for release by QA Department

Shipment of Kits: 

• Prepare Kits for shipment per Standard Operating Procedures and Project Operating Procedures and in accordance to Required Ship Date
• Assemble, prepare Shipping Boxes labels/Air Waybills for outgoing shipments
• Ensure Kits are shipped via appropriate shipping method; Ground, 2 Day Air, Overnight, etc.
• Carry out other tasks/duties as assigned
• This position does not perform Clinical Laboratory Testing

Qualifications:

Minimum Required:

• High School Diploma or GED
• At least 1-2 years of work experience

Other Required:

• Good attention to detail, excellent documentation skills and must work well in a group environment
• Must be a flexible, agile Team Player who can change activities and directions quickly and respond to a variety of assignments and changing business needs
• Ability to lift and carry between 31-50 lbs.; Ability to lift up to 50 lbs. overhead with assistance; frequently required to sit, stand and walk for prolonged periods; occasionally required to squat, bend, stoop, push, kneel, reach and perform tasks with repetitive motion
• Must be able to read, write, speak fluently and comprehend the English language