QC Production Associate I

1 month ago

Gilroy, United States SOFIE Full time

QC/Production Associate I

Title | QC/Production Associate I

Department | Network Operations

Reports To | Facility Manager

Overview

The QC/Production Associate I will operate the radiosynthesizers for the production of drug product, as well as operate analytical equipment for the quality control of drug product.

Essential Duties and Responsibilities 

  • Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs):
  • Ensure all materials/reagents are accepted according to SOPs and within expiry
  • Ensure all equipment is appropriately qualified prior to use
  • Operate the synthesis unit according to SOPs
  • Learn the basic operational principles of the synthesis unit and assist in routine maintenance of the synthesis unit
  • Perform FDG and NaF quality control (QC) processes according to SOPs: 
  • Assist with basic maintenance of QC equipment
  • Ensure all equipment is appropriately calibrated and qualified prior to use
  • Operate the QC equipment according to SOPs
  • Ensure completion of applicable cGMP documentation. 
  • Assist with inventory management:
  • Maintain production/QC/cleaning supply levels as appropriate
  • Assist with inventory reporting
  • Perform material acceptance according to SOPs
  • Communicate with local and Network support resources to troubleshoot equipment, production, or QC issues.
  • Perform basic computer-controlled cyclotron operations for FDG and NaF production under the advisement of site Cyclotron and Facility Engineer.
  • Maintain a clean and safe working environment.
  • Perform radiation safety duties according to SOFIE’s Corporate Radiation Compliance Program and site licensing requirements.
  • Maintain all qualification and validation requirements for entering ISO classified area. 
  • Clean classified and non-classified areas according to SOPs. 
  • Perform environmental monitoring of classified areas according to SOPs.
  • Report manufacturing metrics into data repository as required.  
  • Complete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to: 
  • Investigations
  • Corrective and Preventative Actions
  • Deviations 
  • Out of Specifications 
  • No or Atypical Yields 
  • Manufacturing and QC Records 
  • Logbooks  
  • Attend internal meetings as required. 
  • Other assigned duties as required.  

 

Qualifications 

  • High school diploma required; associates degree in chemistry, engineering, or natural sciences preferred. 
  • Technical experience with computer-controlled automation preferred.  
  • Efficient in the use of MS Office Suite required. 
  • Ability to work various shifts and weekends required. 
  • Ability to be detail-oriented, accountable, patient, organized, and work in a team environment required.  
  • Ability to communicate professionally with colleagues and customers, have excellent attention to detail, and be dependable and responsible in a fast-paced, highly technical environment required.  
  • Ability to lift ~50 lbs. required.  
  • Up to 5% travel required. 

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