QC Production Associate I (Chemist)

Company: SOFIE
Location: Somerset
Posted on: May 28, 2023

Job Description:

OverviewThe QC/Production Associate I will operate the radiosynthesizers for the production of drug products, as well as operate analytical equipment for the quality control of drug products.Essential Duties and Responsibilitieso Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs):o Ensure all materials/reagents are accepted according to SOPs and within expiryo Ensure all equipment is appropriately qualified prior to useo Operate the synthesis unit according to SOPso Learn the basic operational principles of the synthesis unit and assist in routine maintenance of the synthesis unito Perform FDG and NaF quality control (QC) processes according to SOPs:o Assist with basic maintenance of QC equipmento Ensure all equipment is appropriately calibrated and qualified prior to useo Operate the QC equipment according to SOPso Ensure completion of applicable cGMP documentation.o Assist with inventory management:o Maintain production/QC/cleaning supply levels as appropriateo Assist with inventory reportingo Perform material acceptance according to SOPso 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 Investigationso Corrective and Preventative Actionso Deviationso Out of Specificationso No or Atypical Yieldso Manufacturing and QC Recordso Logbookso Attend internal meetings as required.o Other assigned duties as required.Qualificationso 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.PDN-993554a4-5b20-4ef0-8da5-231e7684c0af

Keywords: SOFIE, Trenton , QC Production Associate I (Chemist), Professions , Somerset, New Jersey