QC Production Associate I
hace 2 meses
Franklin Township
Join our team as a QC/Production Associate I, where you'll play a key role in producing life-changing drug products and ensuring their quality through hands-on work with advanced radiosynthesizers and analytical equipment. Title | QC/Production Associate I Department | Network Operations Reports To | Facility Manager Compensation: $25-$27/hr Overview 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 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 • 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.