Cardinal Health PET Manufacturing Services is responsible for manufacturing PET (Positron Emission Tomography) isotopes to enhance patient treatment through improved disease diagnosis, staging, and monitoring.
Leveraging our fully integrated network of domestic nuclear pharmacies, Cardinal Health PET Manufacturing Services compounds, dispenses and distributes patient-specific, unit-dose PET products in pharmacy markets today.
What Chemical/ Pharmaceutical Ops contribute to Cardinal Health
Operates automatic and manual manufacturing and chemical process equipment of varying complexity in various production processes in accordance with operating procedures. Performs a variety of tasks related to the processing of ingredients and/or pharmaceutical products. Handles raw materials and intermediate or finished products. Mixes compound ingredients for liquid products, suspensions, ointments, mixes, or blends for tablet granulations and capsule powders. May perform general maintenance as required on pumps, homogenizers, filter presses, tablet compression machines, etc. Performs standard operating procedures to meet current good manufacturing practices (GMP). Maintains records as required. May monitor and verify quality in accordance with statistical process or other control procedures.
What is expected of you and others at this level in Manufacturing for functional success
- Applies basic skills and techniques to complete routine tasks within assigned area
- Maintains appropriate licenses, training and certifications
- Works on basic and routine assignments
- Works within clearly defined Standard Operating Procedures and/or scientific methods
- Adheres to all quality guidelines
- Works under close supervision. All work is reviewed for accuracy
- Any deviations from the norm are approved by the supervisor before proceeding
Accountabilities in this role
- Be able to successfully complete extensive required training, including e-learning assignments and hands on components, to demonstrate and maintain proficiency.
- Follow Standard Operating Procedures (SOP) without deviation, to characterize materials, monitor chemical reactions and assure quality of final products.
- Understand and adhere to all Certified Good Manufacturing Practices (cGMP) to ensure compliance and regulatory mandates are met.
- Demonstrate strong documentation practices, oral communication, and writing skills. Perform clerical and administrative services including maintenance of daily delivery records, report preparation and maintenance records.
- Perform general laboratory and facility clean up.
- Learn and practice FDA regulations as they pertain to the job function
- Location: Roseville, MN
- Must be able to work overnight shift (Facility operates at night.)
- Shift starts 10pm or midnight
- 2 Saturdays a month
- Science degree preferred not required
- Prior experience in manufacturing, preferably in a controlled environment and/or regulated industry desired but not required
- 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.
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.