QC / Production Associate I Title QC / Production Associate IDepartment Network OperationsReports To Facility Manager OverviewThe 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 expiryEnsure all equipment is appropriately qualified prior to useOperate the synthesis unit according to SOPsLearn the basic operational principles of the synthesis unit and assist in routine maintenance of the synthesis unitPerform FDG and NaF quality control (QC) processes according to SOPs : Assist with basic maintenance of QC equipmentEnsure all equipment is appropriately calibrated and qualified prior to useOperate the QC equipment according to SOPsEnsure completion of applicable cGMP documentation.

Assist with inventory management : Maintain production / QC / cleaning supply levels as appropriateAssist with inventory reportingPerform material acceptance according to SOPsCommunicate 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 : InvestigationsCorrective and Preventative ActionsDeviations Out of Specifications No or Atypical Yields Manufacturing and QC Records Logbooks Attend internal meetings as required.

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.

Last updated : 2024-06-06