QC / Production Associate I

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

J-18808-Ljbffr