Jan 08, 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 Control Analyst will be responsible for Quality Control Chemical and Microbiological testing of Product and Raw Materials/packaging components as well operation/maintenance of analytical instrumentation in accordance with cGMP/FDA regulations, AAA standard operating procedures and Policies. Due to the nature of the process (radioactive) this role requires moderate proficiency, of the basic quality control techniques, analytical instrumentation, sterility principles and understanding of radiation safety standards.

General responsibilities will include but are not limited to the following:

• Supports all technical aspects related to quality control testing readiness including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing, in full compliance with GMP regulation, AAA procedures and Product specifications
• Responsible for the oversight on Manufacturing for QC sampling activities
• Product testing and Environmental Monitoring QC testing and reporting of the results. Escalate in case of non-conformances and deviations, and manage these quality incidents as per AAA procedures
• Assist on deviation investigations, OOS/OOT investigations, CAPAs follow up and implementation and Change Controls
• Participation in assigned qualification/validation activities, as necessary; Responsible for successful on time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications, Testing and specifications and other relevant training including HSE for the specific role
• Prepares applicable documents, forms and records such as analytical batch records and follows Good Documentation Practices and Support Audits and Inspections 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

What you’ll bring to the role:

Bachelor’s degree in relevant Scientific discipline (e.g. Chemistry, Microbiology) is required

Experience & Requirements:
• A minimum of 2 years of experience in cGMP or aseptic environment is required
• Knowledge of cGMP regulations and FDA guidance applicable to Quality Control for product and Environmental Monitoring testing, Aseptic techniques required
• Basic knowledge and understanding of aseptic principles and techniques required
• Practical experience with physio-chemical techniques, and analytical instrumentation such as HPLC, GC, iTLC is highly preferred
• Basic knowledge of method/equipment validation principle and methodologies are required
• Ability to interpret analytical data and convert into technical documentation

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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Quality Control Analyst

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