391822BR

USA

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Quality Engineering professionals to help us reach our ambitious quality and validation goals.
The QA Engineering Specialist will be responsible for Quality oversight of manufacturing, testing and supply chain operations to ensure compliance with current GMP regulations, Radioligand Therapy procedures and systems. This role includes oversight of operational activities, validation activities and continuous process improvement.
Key Responsibilities:

• Provides Quality oversight to manufacturing, testing, and distribution and support staff as needed to identify and resolve product quality and compliance issues as they arise
• Develop, maintain, and propose continuous improvement of quality systems and policies for production, MS&T, engineering, and supply chain according to Novartis Global Quality Standards, applicable local and global regulatory requirements, and registered Product information.
• Drive continuous quality improvement program for aseptic manufacturing operations and partner with the production, engineering, and supply chain teams to implement/optimizes to improve efficiency (right the first time) and monitor/escalate as needed.
• Ensures manufacturing processes, facility, equipment and software are properly qualified and validated for GMP use.
• Ensures OOS, deviation, change control processes are properly followed, provide QA decisions and approval for these exceptions. Ensure that investigation determine root cause, impact assessment and appropriate preventative/corrective actions. Ensure timely closure of investigations, and proper escalation to management as per local and global procedures.
• Monitors QA process and manage communication and reporting according to a defined frequency
• Support employee training to diffuse new regulations and policies.
• Collaborate with other departments to create/review risk assessments
• Serves as SME for the GMP regulatory inspections

Role Requirements

• Bachelor’s degree in scientific or health related field
• 5+ years of relevant GMP work experience, or relevant comparable background and
• 2+ years of relevant QA experience preferred.
• Experience conducting quality investigations, root cause analysis and quality risk assessment
• Knowledge of GMP standards.
• Strong background in aseptic processing/microbiology.
• Strong organization, communication and presentation skills
• Excellent interpersonal and communication skills.
• Demonstrates strong personal ethics and responsibility.
• A strong team player and effectively collaborates with internal departments.
• Demonstrates and role models the Novartis values and behaviors.

The pay range for this position at commencement of employment is expected to be between $92,800 and $139,200 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and 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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network