Location(s): United States; Illinois; Arlington Heights
About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry. GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Role Summary: Performs operations related to the manufacturing of radioactive products and the manufacture of final product radio chemicals and radiopharmaceuticals from raw materials. All manufacturing operations must be performed in accordance with federal regulations, current Good Manufacturing Procedures (cGMPs) and GEHC Standard Operating Procedures (SOPs). 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.
Prepare and set-up of associated equipment and materials, i.e. ion chambers, autoclaves, etc.
Comply with all applicable Environmental Health & Safety (EHS), Health Physics, Quality System Requirements (QSRs) and Personal Protective Equipment (PPE) requirements.
Strict adherence to cGMP, always.
Perform housekeeping in accordance with 5S policy.
Perform Preventative Maintenance (PMs) as required/assigned.
Troubleshoot basic equipment problems by communicating with SME.
Assist in writing Investigation Reports (IRs) and Unscheduled Work Orders (UWOs).
Utilize Trackwise program and internal document control program.
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.
Able to perform shift/weekend work as required and allowed.
Must be able to lift 35 lbs. or more.
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.
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.
Ability to multi-task.
Background in Chemistry.
Locations: United States; Illinois; Arlington Heights
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