o Perform troubleshooting and emergency maintenance of equipment.
· Ensure completion of applicable cGMP documentation.
· Assist with inventory management:
· Maintain production/QC/cleaning supply levels as appropriate
· Perform material acceptance according to SOPs
· Communicate with local and Network support resources to troubleshoot equipment, production, or QC issues.
· Perform basic computer-controlled cyclotron operations for multiple drug products’ production under the advisement of site Cyclotron and Facility Engineer.
· Maintain a clean and safe working environment.
· Perform radiation safety duties according to SOFIE’s Corporate Radiation Compliance Program and site licensing requirements.
· Maintain all qualification and validation requirements for entering ISO classified area.
· Clean non-classified areas according to SOPs.
· Report manufacturing metrics into data repository as required.
· Complete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to:
· Investigations
· Corrective and Preventative Actions
· Deviations
· Out of Specifications
· No or Atypical Yields
· Manufacturing and QC Records
· Logbooks
· Attend network meetings as required.
· Other assigned duties as required.
Qualifications
· High school diploma required; Associate degree in chemistry, engineering, or natural sciences preferred.
· Technical experience with computer-controlled automation preferred.
· Efficient in the use of MS Office Suite required.
· Ability to work various shifts and weekends required.
· Ability to be detail-oriented, accountable, patient, organized, and work in a team environment required.
· Ability to communicate professionally with colleagues and customers, have excellent attention to detail, and be dependable and responsible in a fast-paced, highly technical environment required.
· Ability to lift ~50 lbs. required.
· 40-60% travel (based on network needs)
The description provided above is not intended to be an exhaustive list of all job duties, responsibilities, and requirements. Duties, responsibilities, and requirements may change over time and according to business need.