Job Description 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.
Job Description Shift: (Sun-Wed 2:30pm-1:00am) 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.Follow 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).Assist in evaluation of new and existing analytical methods being transferred to or from the site by utilizing a risk-based approach.Contribute, support, and lead writing of OOS/OOE/OOT and deviation investigations.Drive 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: EnglishWhy 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! Salary Range: $97,600.00 - $146,400.00
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives.
Accessibility and reasonable accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
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