343835BR
May 09, 2022
USA

Job Description

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking 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!

The Senior QC Analytical Chemist is responsible for performing tasks associated with release testing and reviewing laboratory data. Communicating with and supporting internal & external partners of the Quality Control organization. Supports site as technical expert in related field.

Your responsibilities include, but are not limited to:

• Provide support to peers within the Quality Assurance, Quality Control, Engineering and Production teams.
• Author, review and support procedures, investigations, corrective and preventive actions, change
controls, complaints and training as it relates to quality control testing.
• Ensure that QC testing is properly conducted and documented for all performed activities, with
emphasis on Data Integrity. Evaluate and approve QC records as required.
• Perform QC related validations, transfers, improvements, investigations related activities (deviations,
OOS, OOE, OOT, CAPAs, trending), and Change Control systems.
• Performs relevant QC testing, such as high-performance liquid chromatography (HPLC), instant thin layer chromatography (ITLC), UPLC, endotoxin testing, and radiochemical purity testing as required.
• Provide oversight and monitoring of quality control KPIs and programs.
• Support Quality Control as a valued business partner, with a culture of safety, quality,
delivery to patients, cost, compliance and data integrity.
• Support the determination of Laboratory equipment layout, design, qualification, and operation to
optimize the usage of the laboratory by increasing flexibility, reducing complexity, optimizing use of
capital and compliance with cGMP. Maintain fit for purpose labs in the future.
• Prepare and participate in health authorities’ inspections and internal audits of QC. Ensure quality
control area is inspection ready.
• Ensure that all planned, executed, and documented activities are aligned with Quality Manuals/GOPs, company, and site policies.
• Follows cGMP, GLP, and GDP quality policies and procedures.

https://www.youtube.com/watch?v=4A1joFLTfo0

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 Pharmacy, Biotechnology, Chemistry or relevant scientific field
7+ years of experience in a GMP quality control environment
• Experience in UPLC/HPLC, LCMS, and/or GCMS GMP operations
• Experience in trouble shooting techniques HPLC, LCMS, and/or GCMS in GMP operations
• Familiar with current ICH and USP guidance for analytical method validations
• Knowledge with the analytical equipment and Part 11 software, including but not limited to Chemstation™, Chromeleon™, EMPOWER™, and Laboratory Information Management System.
• Excellent technical writing experience in a regulatory environment such as protocols, reports, and SOPs
• Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment

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 embraces diversity, equal opportunity, and inclusion. 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.

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 [email protected] 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 learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
USA
Millburn, NJ
Quality
Full Time
Regular
No
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343835BR

Sr QC Analytical Chemist

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