About this role
Description:
Overview
The 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 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.