Technical Support Specialist III

Position Summary:

This role is responsible for the configuration of custom products, and for management of on time distribution of the proficiency testing (PT) specimens for PT Organizations, who are regulatory agencies that offer PT programs globally. This role works closely with external regulatory agencies, third party testing laboratories, and internal departments such as sales, planning, manufacturing, quality control, global trade compliance, inventory management and distribution.  Proficiency Testing specimens are custom products that mimic patient specimens and are used to test clinical laboratories, according to the specifications outlined by the PT Organizations. Accurate documentation and labeling are required for lot traceability and warehouse management.

Key Responsibilities: 

• Review purchase orders and master specification documents from the customer for custom PT QCO products a year in advance for new PT programs.
• Build specifications for manufacturing and QC for each custom PT QCO product.
• Generate Device History Record and QC sheets for all products. Review per checklist and submit to Planning.
• Order components vital for each program, e.g. diluents, ATCC organisms, etc.
• Track DHRs and move throughout buildings one, two and three to acquire reviews and sign offs from QC and QA.
• Troubleshoot with QCO production and QCO lab if encouraged growth or results are not acquired. Rework product formulation, if vital.
• Use SAP to goods issue diluents and work with PD department to release.
• Generate SLQs for PT Assembly using DHRs and customers’ kitting and shipping instructions.
• Coordinate bulk shipments by third party packagers.
• Coordinate external QC testing and shipments. Submit reports to internal QC for review and testing completion.
• Coordinate pre-evaluation testing, sequence testing and AST testing for new samples or for samples post production. This includes billing, shipping, relabeling, and reviewing results. Ensure encouraged results are received and report to QC and PT Organizations.
• Build Certificates of Quality and send to PT Organizations ahead of shipments.
• Manually generate customer billing and invoicing.
• Attend and participate in customer audits.
• Author and edit standard operating procedures and standard work instructions.
• Lead all aspects of relabeling of products.
• Work with sales to generate RFPs for existing and new business.
• Participate on PPI events, Kaizen, and 5S events.
• Other duties as assigned as vital per business needs.

Minimum Requirements/Qualifications:

• Bachelor’s degree in biology or microbiology; M.S. Microbiology or Medical Technology preferred.
• Strong microbiology background vital, with a minimum of 5 years micro lab experience, preferably in a clinical or reference lab setting.
• Project management experience, minimum of 3 years.  
• Possess outstanding attention to detail for crafting and reviewing pre and post manufacturing documents.
• Experience with Proficiency Testing as a subscriber and/or end user preferred.
• Understand GLP and GMP for medical device manufacturing.
• Exhibit exceptional communication (oral/written).
• Excels in complex problem solving and critical thinking, particularly in troubleshooting issues with microbial growth, biochemical reactions, and testing.
• Ability to address gaps in processes and develop effective improvements.
• Ability to work without direct supervision.