Bioprocessing Manufacturing Technician
 
Kelly® Science & Clinical is seeking a Scientist for a contract-to-hire position at a cutting-edge biomanufacturing company in Carlsbad, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate:  
$20-24/hour, depending on experience

Overview:
This client is an industry-leading CMO focused on life science and In-vitro Diagnostic kits.
 
Schedule: 
Monday-Friday, 6:00am-2:30pm
 
Responsibilities:

• Ability to work within an ISO 13485 and cGMP production environment and ensure compliance with quality system.
  

• Execute documentation based on cGMP and GDP procedures, as well as perform documentation review post manufacturing execution. Conduct daily documentation review.
  

• Responsible for formulation of liquid assays, operation of large equipment, creating lyophilized product in an ISO cleanroom environment, daily washing of regularly used tools.
  

• Visual inspection of lyophilized product and heat seals of packaging.
  

• Clean and sanitize manufacturing and associated support areas.
  

• Responsible for monitoring machinery and reporting alarms to lead technician or Supervisor.
  

• Employee may be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
  

• Handling of liquid nitrogen according to OSHA safety guidelines.
  

• Lifting of heavy liquid nitrogen Dewars using proper body mechanics.
  

• Loading/Unload materials to automated machines and lyophilizers.
  

• Responsible for Biodecontamination and appearance of all formulation and lyophilization production areas.
  

• Prepare liquid solutions for freezing into solid product.
  

• Perform daily arithmetic calculations as it pertains to total volume and liquid concentrations.
  

• Perform daily unit conversions as it pertains to gravimetric and volumetric measurements.
  

• Operate production equipment such as pipettes, balances, pH meter and heat sealers.
  

• Monitor department equipment for proper operation that is within calibration.
  

• May perform safety and cGMP inspections or observations.
  

• Ensure compliance with SOP/cGMP and cGDP requirements.
  

• Assist in training/ leading of new team members in production activities.
  

• Assist in updating and new revision of standard operating procedures (SOP).
  

• Author Non-Conformance Reports (NCR) and risk analysis memos.
  

• Receive and distribute supplies into the production area as necessary.
  

• Participate in Quality Working Teams and Continuous Improvement Teams.
  

• May assist with review of quality assurance logbooks.
  

• May perform other duties as assigned.

Qualifications:

• High School Diploma
  

• Experience with calipers, micrometers, and soldering equipment. 
  

• 1+ years of relevant GMP experience.

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