Production Technician; CO, Golden

Overview

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.

• Ensure the product is manufactured according to established specifications, manufacturing instructions, and standard operating procedures, including visually monitoring the product and performing in-process product sampling and testing
• Maintain cleanliness standards to meet ISO cleanroom classification
• Operate blenders, tablet presses, tablet deduster, scales, hardness testers, metal detector, tablet counter, capsule making equipment, magnifying lenses, mixer, and hot plates per SOPs and monitor equipment for upcoming calibration dates
• Complete production records according to specifications
• Follow GMPs, safety rules and regulations as embodied within SOPs
• Dispense, weigh and mix ingredients for batch production
• Sample incoming components and fill out sample submission forms
• Follow Batch Production Records, Maintenance Manuals, and various forms
• Comprehend and complete the manufacturing paperwork required for batch record processing, including labels, logbooks, production batch records, maintenance, and calibration
• Perform simple math calculations required for batch processing, such as determining loss amounts, process yields and accountabilities and reconciliations
• Clean tools, supplies, equipment, production processing rooms, storage rooms and general areas in accordance with Standard Operating Procedures
• Maintain personal training qualifications
• Wear personal protective equipment
• Other duties as may be assigned

TRAINING

• Experience:
  
  Minimum of 5 years of experience in facilities management or equipment maintenance in a regulated environment, with at least 2 years in a supervisory or managerial role. Experience in a pharmaceutical or healthcare environment is highly preferred.
• Technical Expertise:
  Strong knowledge of pharmaceutical compounding equipment, cleanroom technology, HVAC systems, and other essential equipment in a pharmaceutical manufacturing environment.
• Knowledge of Safety Protocols:
  Familiarity with health and safety guidelines and OSHA regulations, with a focus on maintaining a safe working environment.

• Bachelor’s Degree:
  Required in Engineering, Facilities Management, Industrial Management, or a related field.
• Certifications (Preferred):

As part of your job duties, travel may be required. If applicable, you will be compensated at the current IRS mileage reimbursement rate.

Tuesday-Friday, 7:00 AM- 5:30 PM
Monday-Thursday, 7:00 AM- 5:30 PM