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Description

• The position may perform or assist in the setup, inspection, preventive maintenance, troubleshooting and cleaning of equipment used throughout the BacT/ALERT Manufacturing and Packaging processes.
• Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks
• AQL inspections, reworks and Material reconciliation that goes along with the batch.

• Production:
  • Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces
  • Chemical weighing and reagent formulation
  • Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs
• Quality:
  • Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner
  • Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations
  • Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.
  • Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns
  • Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements
  • Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications.
  • Perform self-audit of rooms and processes
    
  • Train and certify teammates on production processes and procedures
• Safety:
  • Comply with all safety policies and procedures at all times
  • Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.
• Other Duties:
  • Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making
  • Work with other departments and assist with executing validation protocols associated with 
    manufacturing/packaging equipment and procedures including revalidation as scheduled or required to 
    maintain systems in a validated state
  • Assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state
  • Perform computer applications
  • Communicate with Materials Management, Production Operations, and Quality Control on a daily basis to 
    ensure the timely and efficient production of all of our customer requirements
  • Perform other duties as assigned by Management

• High School Diploma or GED Required with 2+ years in a regulated production/operations environment
  • Associates Degree in an applicable or Technical field or Vocational / Technical School preferred
    
• Certification in a Bioworks Program or equivalent is preferred
• A basic chemistry and lab application experience strongly desired 
• Background in bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is desired
• Familiarity with measurement scales, mixing, blending, chemical mills, and other formulation manufacturing equipment strongly desired
• Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.
• Knowledge of FDA and/or GMP regulations preferred.
• Mechanical background preferred.

Physical Requirements:

• Ability to remain in stationary position, often standing, for prolonged periods.
  
• Ability to ascend/descend stairs, ladders, ramps, and the like.
  
• Ability to wear PPE correctly most of the day.
  
• Ability to operate heavy machinery.
  
• Ability to adjust or move objects up to 50 pounds in all directions.

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BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).