Job Description Summary Under general direction, perform testing and other activities in functions supporting the Quality Control department (Micro/EM, QC Bio-assay, and raw materials, as appropriate).
Job Description Shift: (Wed - Sat 2:30pm-1am) 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: Perform Bio-Analytical testing such as Flow, ELISA, cell count, cell viability, qPCR as well as micro/EM testing such as environmental monitoring, gram stain, sterility, endotoxin, and mycoplasma.Perform raw material testing such as HPLC, GC, FTIR, osmolarity, UV/VIS, polarimeter, refractometer, and viscometer.Maintain controls and reference standards to support testing. Maintenance of Cell Lines and cell banks.Review/approve data generated by other team members.Perform method qualification/optimization of methods as per appropriate protocols.Contribute to OOS/OOE investigations and deviation investigations.Knowledge of LabWare LIMS and/or other QC data systems.Maintain GMP/GLP quality systems and follow quality policies.Role Requirements: BA or MS in chemistry, biochemistry, microbiology, or other related science AND 0 - 5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO, etc.).Knowledge of microbiological and environmental monitoring, bioassay, and/or raw material test methods, as appropriate.Knowledge of LIMS systems.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.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!
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.
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.
Salary Range: $69,300.00 - $103,900.00
Skills Desired:
Agility, Audit Management, Business Partnering, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Sop (Standard Operating Procedure), Technological Expertise.
#J-18808-Ljbffr