379554BR

USA

About the role

Quality Assurance (QA) Operations Specialist

Location: Millburn, NJ #LI-Onsite

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 experienced QA professionals to help us reach our ambitious goals.

The Quality Assurance Specialist will be responsible for supporting oversight of manufacturing, testing and supply chain operations to ensure compliance with current GMP regulations and the Novartis SOP's and systems.

Overall duties:
o Provide QA support of production, engineering, and supply chain operations through review/approval of test records for batch release, SOPs, CAPAs, Deviations, change controls, and shop floor oversight. Provides the production, engineering, and supply chain teams with QA/Compliance guidance and decisions.
o Review and approve Standard Operating Procedures, Quality Risk Assessments, Quality Plans related to manufacturing operations, as needed. Contribute to generation of Annual Product Reviews for production, engineering and supply chain.
o Support continuous quality improvement program for manufacturing operations and partner with the production, engineering, and supply chain teams to implement/optimizes to improve efficiency and monitor/escalate as needed.
o Supports all regulatory inspections related to preparedness initiatives and executions of the inspections.
o Provide cGMP and associated OJT training to any other quality members and other operational areas as needed.
o Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.

When hired, you will focus on Shop Floor OR Batch Release specific responsibilities:

* Shop floor oversight:
o Supports QA Operations programs especially related to batch release activities and shop floor programs which includes Visual Monitoring on Surprise, GEMBA walkthrough program, equipment/area/utility out of service program, QA area release of classified and unclassified areas, QA media fill oversight programs, event triage and support of routine operations.
o Assist in triaging when an event or issue arises during manufacturing operations

* Batch Record Review and Release:
o Review/approve investigations of excursions in production, engineering, and supply chain operations. Support resolution of major and critical quality events, monitor that recurrent events are properly escalated and resolved. Ensure root cause is determined, evaluate impact on product quality, disposition, and corrective actions.
o Perform final review of production data test data/reports to ensure conformance to the established specifications and standard operating procedures. Act as Responsible Person for the final disposition of products.
o Follow the scheduling of tasks set forth by the QA operations Lead or Head for batch record issuance and record review and release activities

NOTE: This is a 2nd shift position

EEO Statement

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.

Role Requirements

Essential Requirements
Education: Bachelors' Degree, preferably in Life Sciences, chemistry or related relevant degree.

Experience:
2+ years of experience in a GxP Biopharmaceutical manufacturing operations
1+ years of experience in a quality assurance role
Experience working in a matrixed organization
QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones

The pay range for this position at commencement of employment is expected to be between $88,000.00 and $132,000.00 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

Division

Operations

Business Unit

QUALITY

Work Location

Millburn, NJ

Company/Legal Entity

AAA USA Inc.

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular

Shift Work

Yes

Early Talent

Yes