QC Production Associate I (Chemist) | Dallas, TX

Detailed Information

  • Location: Dallas, TX

  • Company: Sofie

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 Na F 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 c GMP 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 Na F 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 c GMP 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. 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. PDN-9ae5d4ff-9b58-485d-b559-965425c1875d

View Jobs by Category >>

Related Jobs