Senior QA Operations Specialist

Oct 01, 2021

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 Senior QA Operations Specialist is responsible for quality assurance oversight of manufacturing, testing and supply chain operations with current GMP regulations, procedures and quality systems.

Your responsibilities include, but are not limited to:

• Provide shop floor oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity & eCompliance. Ensure timely escalation to management of all applicable incidents.
• Review, approve and support procedures, investigations, corrective and preventive actions, change controls, complaints, training and production/testing records as required.
• Ensure timely and compliant final product disposition of the product.
• Review manufacturing batch records and execute product release in compliance with registrations. 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.
• Establish site Sterility Assurance program, implement governance to ensure compliance of site personnel and application of aseptic techniques, Site Microbiological control strategy and trending (EM and Product) and full compliance to sterile manufacturing regulations.
• Support commercial product FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and audits.
• Provide support to peers within the QA Operations team.

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

What you'll bring to the role:

Bachelor’s Degree in a scientific or health related field
5-7+ years of experience in a GMP production environment
3+ years of experience in a sterile manufacturing
3+ years of experience in a GMP QA environment

• Collaborating across boundaries
• Functional Breadth
• QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones
• Proven track record and practical experience in leading a quality operations unit that operated in full compliance with global cGMP requirements and successfully managed inspections from major Health Authorities including USA, EMEA, Canada, Japan, Brazil
• Proven ability to manage multiple projects with moderate resource requirements, risk and/or complexity
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:
Indianapolis, IN
Full Time
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Senior QA Operations Specialist

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