QC/Production Associate I

About the role

Join our team as a QC/Production Associate I, where you’ll play a key role in producing life-changing drug products and ensuring their quality through hands-on work with advanced radiosynthesizers and analytical equipment.

Compensation: $25/hourly

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; associate's 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

Schedule

Ability to work various shifts and weekends required.