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What Nuclear Manufacturing contributes to Cardinal Health
Nuclear Manufacturing is responsible for the manufacturing of time sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (i.e. FDA, NRC, DOT) to support patient treatment through disease diagnosis, staging, and monitoring.
The primary work environment consists of a cyclotron and associated manufacturing facility for the production of PET radiopharmaceuticals, which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.
Accountabilities in this role Successfully complete extensive training, including e-learning assignments and hands on components, to demonstrate and maintain proficiency
- Manufactures radioactive isotopes (includes synthesis set up, hot cell manipulations, distribution)
- Conducts quality control testing of each batch (utilizing gas chromatograph, dose calibrator, multi-channel analyzer, TLC plate scanner, high pressure liquid chromatograph, analytical balance, PTS, laminar flow hood and fume hood)
- Works in ISO 7 cleanroom to make product vials and customer vials for use in drug production
- Performs environmental and personnel monitoring in ISO 5, ISO 7, and ISO 8 environments
- Coordinates daily production run schedule based on customer and pharmacy needs
- Demonstrates strong documentation practices, oral communication, and writing skills. Performs clerical and administrative tasks, including maintenance of daily production records, report preparation and maintenance records
- Manages SAP Inventory (includes receiving materials, properly inspecting materials for use, and maintaining proper cycle counts)
- Performs daily radiation safety tasks, along with general lab cleaning
- Education in sciences preferred
- Lab experience highly preferred
- Must be able to work overnight shift (Facility operates at night.)
- Prior experience in manufacturing, preferably in a controlled environment and/or regulated industry desired.
- Effective written and verbal English communication skills required
- Able to repeatedly follow detailed processing instructions
- Ability to manage several tasks at the same time; Ability to evaluate operating conditions and exercise sound judgment and problem solving skills.
- Lifting: Frequent lifting between 50-75 lbs.
- Ability to see fine particulate and differentiate colors in liquid solutions.
- Ability to hear, write (English), and speak (English) clearly in order to communicate in manufacturing setting.
- Manual dexterity required for equipment operation and occasional reach and lifting of small objects.
- Ability to be an effective team member.
What is expected of you and others at this level in Nuclear Manufacturing for functional success
- Ability to execute Standard Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMP) requirements including Good Documentation Practices (GDP)
- Ability to monitor and verify quality in accordance with SOPs
- Ability to perform general maintenance
- Ability to work in and maintain a sterile environment, including required cleaning of equipment and facility
- Work in partnership with cross functional teams to ensure product/production expectations and demands are met
- Disciplined approach to adhering to a large volume of SOPs, with the ability to adapt to process improvements
- Ability to learn and utilize technology to support manufacturing processes
- Ability to manage inventory
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.