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Role Summary: 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.
Qualifications/Requirements: Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Complete all planned Quality & Compliance training within the defined deadlines
Identify and report any quality or compliance concerns and take immediate corrective action as required
Associate’s degree (or local equivalent), some experience working in a healthcare or related manufacturing environment; or High School diploma/ equivalent plus some 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.
Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website
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