QC​/Production Associate

Position: QC/Production Associate I
Description:

Overview The QC/Production Associate I will operate the radio synthesizers for the production of drug products, as well as operate analytical equipment for the quality control of drug products.

Essential Duties and Responsibilities o Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs): o Ensure all materials/reagents are accepted according to SOPs and within expiry o Ensure all equipment is appropriately qualified prior to use o Operate the synthesis unit according to SOPs o Learn the basic operational principles of the synthesis unit and assist in routine maintenance of the synthesis unit o Perform FDG and NaF quality control (QC) processes according to SOPs: o Assist with basic maintenance of QC equipment o Ensure all equipment is appropriately calibrated and qualified prior to use o Operate the QC equipment according to SOPs o Ensure completion of applicable cGMP documentation.

o Assist with inventory management: o Maintain production/QC/cleaning supply levels as appropriate o Assist with inventory reporting o Perform material acceptance according to SOPs o Communicate with local and Network support resources to troubleshoot equipment, production, or QC issues. o Perform basic computer-controlled cyclotron operations for FDG and NaF production under the advisement of site Cyclotron and Facility Engineer. o Maintain a clean and safe working environment.

o Perform radiation safety duties according to SOFIE’s Corporate Radiation Compliance Program and site licensing requirements. o Maintain all qualification and validation requirements for entering ISO classified area. o Clean classified and non-classified areas according to SOPs. o Perform environmental monitoring of classified areas according to SOPs. o Report manufacturing metrics into data repository as required. o Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.

o Complete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to: o Investigations o Corrective and Preventative Actions o Deviations o Out of Specifications o No or Atypical Yields o Manufacturing and QC Records o Logbooks o Attend internal meetings as required. o Other assigned duties as required. Qualifications o High school diploma required;

associate’s degree in chemistry, engineering, or natural sciences preferred. o Technical experience with computer-controlled automation preferred. o Efficient in the use of MS Office Suite required. o Ability to work various shifts and weekends required. o Ability to be detail-oriented, accountable, patient, organized, and work in a team environment required. o 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.

o Ability to lift ~50 lbs. required. o Up to 5% travel is required.