Povzetek
About the Role
Major Accountabilities
• Executes all activities related to the manufacturing of RLT products. Responsibilities include operating and maintaining grade A isolators, focusing on KPI goals as well as ensuring all state, federal and Novartis radiation safety guidelines are adhered to.
• Responsible for successful on time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.
• Conducts routine and dynamic environmental monitoring as required.
• Supports all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators using vaporized hydrogen peroxide.
• Prepares all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.
• Participates in periodic mandatory overtime to ensure process continuity and completion.
• Other duties may be assigned, as necessary.
Key Performance Indicators
• Right First Time Batch Record execution. No recurrent deviations.
• Adherence to Attendance Guidelines and all Safety related procedures
• No major or critical audit findings pertinent to the Grade A isolators or Grade B/C areas.
• Manufacturing compliance/adherent to all GDP/GMP principles
• Aseptic/Cleanroom behavior in accordance with GMP guidelines
Specific Professional Competencies
• Flexibility to don clean room garments and personal protective equipment (PPE).
• Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted.
• Makeup, jewelry, nail polish, perfume/cologne and other potential microbial sources are prohibited in restricted areas.
• Ability to lift or carry up to 35 pounds.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
