Location: Morris Plains,NJ, USA
Summary
In this people management role, the Quality Control Supervisor will coordinate patient throughput and compliance activities within the Quality department as well as support development, validation, and external activities as needed.
About the Role
Shift: (Sun-Wed 7:30am-6:00pm)
Location: Morris Plains, NJ
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Key Responsibilities:
* Execute, supervise, and review in-process, development, validation, and release testing on batches including, but limited to, flow cytometry, IFNg potency, qPCR, cell count and viability
* Follows GxP quality policies and procedures and track critical reagent inventory to allow for seamless operation
* Assist in planning and execution of laboratory studies
* Work with cross-functional stakeholders to meet company timelines and support and manage tracking and trending systems, and programs which assist in the testing, evaluation and monitoring of quality, assay performance and efficiency.
* Author, review, and approve Quality documents (i.e., protocols, reports, SOPs, test methods, technical documents, and risk assessments)
* Assists in evaluation of new and existing analytical methods being transferred to or from the site by utilizing a risk-based approach.
* Contributes, supports, and leads writing of OOS/OOE/OOT and deviation investigations.
* Drives CAPA outcomes
* Revise and/or create SOPs, forms, laboratory test records as required using appropriate electronic systems.
* Support internal and external audits of facility as a recognized SME.
Essential Requirements:
* BA, MS, or PhD in biology, chemistry, biochemistry, microbiology or other related science AND a Minimum of 5 years of experience in Analytical Quality Control, method development, or a technical support function.
* Demonstrated knowledge and skills in multiple analytical techniques and the ability to plan, prioritize and execute multiple tasks simultaneously under tight deadlines
* Experienced in writing OOS/OOE/OOT and/or deviation investigations
* Expertise in ICH and FDA/EMEA GMP requirements
* Ability to manage projects and lead teams utilizing modern project management methodology and tools. Knowledge of statistical tools and methods
* Strong verbal and written technical communication skills, ability to communicate clearly with a variety of individuals in various aspects of Novartis operations
* Knowledge of cGMP, USP and FDA guidelines, Knowledge of LIMS systems, Knowledge of Quality Management Systems, such as Trackwise and Knowledge of Change Control systems, such as Agile PLM
* Detail-oriented with expertise in problem solving and solid decision-making abilities.
Languages:
* English
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:
The pay range for this position at commencement of employment is expected to be between $97,600 and $146,400/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. 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
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Handbook.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patient and communities we serve.
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Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?