QC Production Associate I

About the role

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.

Responsibilities

• Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs)
• Operate the synthesis unit according to SOPs 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 and ensure all equipment is appropriately calibrated and qualified prior to use
• Assist with inventory management, including maintaining production/QC/cleaning supply levels and performing 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 and 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 and clean classified and non-classified areas according to SOPs
• Perform environmental monitoring of classified areas according to SOPs and report manufacturing metrics into data repository as required
• Complete cGMP documents as required and assist site and corporate Quality Assurance, including investigations, corrective and preventative actions, deviations, out of specifications, no or atypical yields, manufacturing and QC records, and logbooks
• Attend internal meetings as required and perform 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