Formulation Tech 2 - Night Shift

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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