Manufacturing Technician

Manufacturing Technician Job description

Summary:

The Manufacturing Technician will manufacture drug products intended for human use at MedisourceRx. The technician will perform associated tasks in critical and non-critical environments such as equipment operation, cleaning, maintenance, environmental monitoring, and other various tasks relating to the production department. This position reports to the Manufacturing Manager. We are looking for a cleanroom technician with at least couple of years of sterile compounding experience.

Core Responsibilities:

• Operate in ISO environments performing essential duties to manufacturing sterile products.
• Routine manufacturing operations including preparation and sterilization of labware, measuring, compounding, filing semi automatically.
• Assist and perform compounding, verifying steps, aseptic processing, container closure, integrity testing, inspecting units for foreign matter, labeling, packaging.
• Complete manufacturing documentation and necessary document control assignments.
• 100% Visual inspection and AQL inspection.
• Competent to perform duties as outlined for material transfer, aseptic processing, and other cleanroom related duties.
  
  

Operations Activities:

• Perform customer service duties, prepare client orders, etc.
• Stock manufacturing materials and components and perform routine expiry audits on released materials
• Perform cleanroom environmental monitoring, cleaning and disinfection, and sterilization techniques
• Maintain records for manufacturing, environmental monitoring, inspections and cGDP processes
• General maintenance of activities related to facility, production, or warehouse
• Perform manual dexterity activities required to process equipment
• Assist with investigations for compounding reports, audits and/or complaints
• Knowledge of compounding terminology and calculations
• Other duties as assigned by management or quality assurance
• Ability to learn and perform pharmaceutical level visual inspection
  
  

Expertise:

Understanding and experience in USP guidelines and manual aseptic manipulations making sterile compounded products

Required:

• Available to work 8-hours shift anytime between 6 am- 7pm.
• Experience as a pharmacy technician preparing compounded sterile products OR experience as a manufacturing technician in a company manufacturing sterile products. Do not apply for this position, if you do not have sterile compounding experience.
• Ability to lift at least 65 pounds and no physical limitation to perform the job of Manufacturing technician.
• Corrected or uncorrected 20/20 vision with no color-blindness, as necessary
• Work in controlled environments and wear personal protective equipment, as necessary.
  
  

Desired:

• Knowledge and experience in cGMP and FDA 21 CFR parts 210 and 211
• Experience participating in a Manufacturing Unit in an FDA approved GMP facility that includes cGMP compliance and sterile product preparation for pharmaceuticals
• Knowledge within the areas of quality control and process validation
• Familiarity and understanding of manufacturing methods related to quality control and sterilization assurance
• Proficient in Microsoft Office: Word, Outlook, Excel, PowerPoint
  
  

Job Type: Full-time

Schedule:

All employees are required to wear a mask, vaccinated and all common areas are cleaned and sanitized at regular intervals.

Experience:

• Sterile filling /manufacturing: 1 year (Required)
  
  

Work Location: One location