Novartis Hiring for Quality Control Supervisor (Wed-Sat PM Shift) job in Morris Plains Full Time

Job Description
365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.
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.
Your responsibilities include, but are not limited to:
Patient Throughput
• 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
• Point of contact when Quality Control Manager is unavailable
• Design and implementation of personnel schedule to allow for seamless patient disposition
• Track critical reagent inventory to allow for seamless operation
• Assist in planning and execution of laboratory studies
• 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)
• Work with cross-functional stakeholders to meet company timelines
• 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
• Assists and supervises equipment and metrology teams in troubleshooting equipment issues
• Revise and/or create SOPs, forms, laboratory test records as required using appropriate electronic systems.
• Follows GxP quality policies and procedures.
• Drives 5S and Lean projects.
• Support internal and external audits of facility as a recognized SME.
• Ensures all assigned training is completed within required time frame.
• Work on shifts covering daytime / evening and one or both weekend days.
Project Management
• Helps maintain progress of projects
• Identifies needs for training courses and development of new skills.
• Supports recruiting activities by participating in interviews and provides candidate assessment in addition to basic activities.
Analytical Development and Optimization
• Optimizes analytical methods as the needs arise or to replace existing ones as needed.
• Supports creation of validation plan and technical reports
• Coordinates validation activities as needed
Compliance
• Ensures that all planned, executed, and documented activities are aligned with company and site objectives.
• Ensures adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations.
Support of Quality partners
• Assists Quality Control, AS&T, and Quality Assurance in investigations of assay-related issues and recommends solutions.
• Provides timely response to requests for support of manufacturing deviations, investigations and change requests.
• Provides technical training to key QC and other personnel as required.
• Evaluates new methods, equipment, and technologies, as needed.
• Provides analytical support to internal and external partners as needed
Support of regulatory submissions and audits
• Assists in preparation to internal and external GMP and HSE audits, including, but not limited to International, Federal (FDA, DEA, EPA, OSHA), State and local regulations as applicable.
• Prepares data, performs the data integrity auditing, and contributes to regulatory submission documents
Other
• Performs or supports other tasks related to Quality and site operations, as needed
This is a Wednesday -Saturday PM Shift position. The shift would be 10 hours, 4 days a week. This position will be located in Morris Plains, NJ and will not have the ability to be located remotely.
Minimum requirements
What you’ll bring to the role:
• A minimum of Bachelor’s degree in Biology, Chemistry, Bio-chemistry, microbiology or other related science. MS or PhD preferred
• A minimum of 5 years of laboratory experience is required. Pharmaceutical industry experience is highly desired
• Supervisory or leadership (ie: leading groups or technical teams) experience
• Demonstrated knowledge and skills in multiple analytical techniques
• Experienced in writing OOS/OOE/OOT and/or deviation investigations
• Knowledge in ICH and FDA/EMEA GMP requirements
• Ability to plan, prioritize and execute multiple tasks simultaneously under tight deadlines
• Ability to manage projects and lead teams utilizing modern project management methodology and tools
• Knowledge of statistical tools and methods
• Proficiency using MS Word, Excel, and MS project
• Knowledge of LIMS systems
• Knowledge of Change Control systems, such as Agile, PLM
• Knowledge of statistical tools and methods
• Strong verbal and written technical communication skills
• Strong interpersonal skill
• Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Strong written and verbal communication skills are essential
Desirables:
• Experience in Analytical Quality Control, method development, or a technical support function is desired
• Knowledge of Quality Management Systems, such as 1QEM or Trackwise is desired

Why Novartis?
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!Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or 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.The pay range for this position at commencement of employment is expected to be between $88,000 and $132,000 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