Production Technician (CO, Lakewood)

This position is responsible for compounding, inspecting, and packaging various products in accordance with written SOPs to meet FDA, USP, cGMP and cGDP compliance standards. This position ensures that product is manufactured according to established specifications, manufacturing instructions, and standard operating procedures which includes visually monitoring product, performing in-process product sampling/testing and analyzing samples for quality.

Responsibilities

• Ensuring the product is manufactured according to established specifications, manufacturing instructions, and standard operating procedures, which includes visually monitoring the product and performing in-process product sampling and testing
• Maintaining cleanliness standards to meet ISO cleanroom classification
• Operates blenders, tablet presses, tablet Deduster, scales, hardness testers, metal detector, tablet counter, capsule making equipment, magnifying Lenses, mixer, and hot plates per SOPs as well as filling out LUM’s. monitor equipment for upcoming calibration dates
• Completes production records according to specifications
• Responsible for following GMP's, safety rules and regulations which are embodied within SOP’s
• Dispense, weighs and mixes ingredients for batch production
• Samples incoming component and fills out sample submission forms
• Follows Batch Production Records, Maintenance Manuals, and various forms
• Ability to comprehend and complete the various manufacturing paperwork required for batch record processing, including labels, logbooks, production batch records, maintenance, and calibration.
• Performs simple math calculations required for batch processing, such as determining loss amounts, process yields and accountabilities and reconciliations.
• Cleans tools, supplies, equipment, production processing rooms, storage rooms and general areas in accordance with Standard Operating Procedures.
• Responsible for maintaining personal training qualifications.
• Required to wear personal protective equipment
• Other duties as may be assigned
  
  

Experience And Qualifications

• Mechanical aptitude
• Ability to put on personal protective equipment and work in a cleanroom environment for extended periods of time
• Excellent communication skills and attention to detail
• Ability to identify problems and work to resolve issues
• Must be able to read, understand and follow GMPs, SOPs, Specs and all guidelines as they relate to the process
• Experience with Microsoft Office Suite (Word, Excel) and ability to utilize various software programs
• Ability to work in a team environment
• Possesses a strong work ethic
  
  

Physical Requirements

• Must possess 20/20 vision (with or without correction) and be able to pass vision and colorblindness test