Performs all operations related to the manufacturing of radioactive medical devices; and manufacture final product radio chemicals and radiopharmaceuticals from raw materials. All manufacturing operations must be performed in accordance with federal regulations, current Good Manufacturing Procedures (cGMP's) and GEHC Standard Operating Procedures (SOP's). Failure to follow policies places GEHC at risk with customers in the medical community and with state and/or federal regulatory agencies.
Inter-departmental communication, teamwork and strict compliance to all state/federal/local procedures and regulations are critical due to the time
sensitive nature of the radioactive products manufactured within this highly compliant, just-in-time manufacturing environment.
Process, assemble, dispense, assay and package radio chemicals, radiopharmaceuticals or radioactive devices in accordance with established procedures.
Accurately review and complete all batch records and related documentation.
Preparation and set-up of associated equipment and materials, i.e. ion chambers, welding units, seed counters, block heaters, autoclaves, etc.
Comply with all applicable Environmental Health & Safety (EHS), Health Physics, Quality System Requirements (QSR's) and Personal Protective Equipment (PPE) requirements.
Strict adherence to cGMP at all times.
Perform housekeeping in accordance with 5S policy perform Preventative Maintenance (PM) as required.
Troubleshoot basic equipment problems by communicating with the Lead Technician.
Assist in writing Investigation Reports (IR's) and initial Unscheduled Work Orders (UWO's).
Utilize Trackwise program to track equipment maintenance and Medina system for web-controlled documents.
Ability to pass all gown qualifications is required for employees who need to perform work in the dilution and filling suite.
Associate's degree (or local equivalent) plus a minimum of 3 months experience working in a healthcare or related manufacturing environment; or High School diploma/ equivalent plus a minimum of 1 year working in a healthcare or related manufacturing environment.
Basic computer/data entry skills.
Must understand oral/written technical English (or local language).
Able to perform shift/weekend work as required and allowed
Must be able to lift 35 lbs or more.
Associates degree plus 2 years experience working in a cGMP manufacturing environment.
Experience working with radioactive materials and/or radioactive isotopes.
Experience working with Access database programs and manufacturing equipment such as ion chambers, autoclaves, pyrogen ovens, counters, micro welders and semi-automated equipment.
Previous experience in roles requiring strong attention to detail.