QC/Production Associate I

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
• Affix 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
• Affix with inventory management
• Maintain production/QC/cleaning supply levels as appropriate
• Affix with inventory reporting
• 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

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