QA Operations Associate

**379766BR** **Job ID:** 379766BR **About the role:** Quality Assurance(QA) Operations Associate Location: Millburn, NJ #LI-Onsite About this role: 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 an experienced Quality Assurance Operations Associate to help us reach our ambitious goals. The Quality Assurance Associate will be responsible for oversight of manufacturing, testing and supply chain operations to ensure compliance with current GMP regulations, procedures and systems. Key Responsibilities: •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 •Responsible for support of manufacturing operations such as batch record issuance and reconciliation activities. •Daily review of GMP documentation generated in support of production activities. This includes conducting independent technical review of documentation post-execution of cGMP activities. •Responsible for review of non-complex investigations to ensure determination of appropriate root cause, impact assessment and applicable preventative/corrective actions. Ensure timely closure of investigations, and proper escalation to management as per local and global procedures. •Responsible for release of incoming material. •Ensure overall state of the facility, equipment’s and GMP processes are in accordance to the applicable procedures. **Position Title:** QA Operations Associate **Role Requirements:** Essential Requirements •Education: Bachelors' Degree, preferably in Life Sciences, chemistry or related relevant degree •1+ years’ relevant GMP/QA work experience •Manage high volume workload in an organized fashion. •Ability to gown aseptically. •Good project management skills. The pay range for this position at commencement of employment is expected to be between $59,900 and $89,900 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 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 **Job Type:** Full Time **Country:** USA **Work Location:** Millburn, NJ **Functional Area:** Quality **Division:** Operations **Business Unit:** QUALITY **Employment Type:** Regular **Company/Legal Entity:** AAA USA Inc. **Commitment to Diversity & Inclusion::** _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._ **Shift Work:** Yes **Early Talent:** Yes