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 • Bachelor's degree with 1+ years of relevant experience, or master's degree in related field • 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.