Apr 26, 2022

Job Description

769 million. That’s how many lives are touched by Novartis products globally. And, while we’re proud of that fact, in this world of digital and technological transformation, we must ask ourselves this: how can we continue to improve and extend even more people’s lives?

The Quality Assurance Specialist will be responsible for oversight of manufacturing, testing and supply chain operations to ensure compliance with current GMP regulations, AAA procedures and systems.

Your responsibilities include, but are not limited to:

Ensure harmonization of QA practice at the NJ site concerning quality issues and keep the quality standard policy up to date according to Corporate, ICH, GMP & FDA guidelines
• Work closely with the production, quality control and supply chain departments to ensure their practice fully adheres to cGMP
• Responsible for authoring, revising and approving standard operating procedures, policies and records
• Ensure facility, equipment’s and software’s are properly qualified and validated for GMP use.
• Ensure Cleaning, Testing and Manufacturing processes are properly validated.
• Daily review of manufacturing batch records for product release. This includes conducting independent technical review of documentation post-execution of cGMP activities. Ensure all specifications are met and that applicable requirements are completed and acceptable.
• Ensure 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.
• Responsible for product disposition decision.
• Monitor QA process and manage communication and reporting according to a defined frequency
• Support employee training to diffuse new regulations and policies
• Participate in Quality Product Review
• Perform an annual product review
• Collaborate with other departments to create/review risk assessments
• Supports audit and inspection as required.



Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

HS Diploma or equivalent required; Associate’s or Bachelor’s degree in a scientific or health related field preferred.

5+ years’ relevant GMP/QA work experience
Experience conducting quality investigations, root cause analysis and quality risk assessment
Knowledge of GMP standards
Strong organization, communication and presentation skills
Excellent interpersonal and communication skills
Ability to work across cultures, especially with AAA European team
Demonstrates strong personal ethics and responsibility
A strong team player and effectively collaborates with internal departments

Why Advanced Accelerator Applications (AAA)?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine?
We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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
Millburn, NJ
Full Time
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QA Operations Specialist

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