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).
About the Role 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 follows 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.
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