Associate Scientist, QCA PM Shift

$69,300 - $103,900/Yr

Novartis - Morris Plains, NJ

Full-time - Entry Level

Morris Plains, NJ

Chemical Manufacturing

About the position

The Quality Control Analyst position at Novartis involves performing various testing and quality control activities to support the Quality Control department, specifically in areas such as Microbiology, Bio-assays, and raw materials. The role requires adherence to GMP/GLP quality systems and involves method qualification, data review, and participation in investigations related to out-of-specification results. The position is based in Morris Plains, NJ, with a shift schedule from Wednesday to Saturday, 2:30 PM to 1 AM.

Responsibilities

• Perform Bio-Analytical testing such as Flow, ELISA, cell count, cell viability, qPCR, and micro/EM testing including environmental monitoring, gram stain, sterility, endotoxin, and mycoplasma.
• Conduct raw material testing using methods such as HPLC, GC, FTIR, osmolarity, UV/VIS, polarimeter, refractometer, and viscometer.
• Maintain controls and reference standards to support testing and manage cell lines and cell banks.
• Review and approve data generated by other team members.
• Perform method qualification and optimization of methods according to appropriate protocols.
• Contribute to OOS/OOE investigations and deviation investigations.
• Utilize LabWare LIMS and/or other QC data systems effectively.
• Maintain GMP/GLP quality systems and adhere to quality policies.

Requirements

• BA or MS in chemistry, biochemistry, microbiology, or related science.
• 0 - 5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.
• Knowledge of cGMP and understanding of GLP, good clinical practices, FDA guidelines, and applicable regulations.
• Familiarity with microbiological and environmental monitoring, bioassay, and raw material test methods.
• Proficiency in LIMS systems.
• Strong communication skills to interact with various individuals in Novartis operations.
• Detail-oriented with problem-solving and decision-making abilities.
• Strong written and verbal communication skills.

Benefits

• 401(k) eligibility
• Paid time off benefits including vacation, sick time, and parental leave
• Sign-on bonus
• Restricted stock units
• Discretionary awards
• Full range of medical and financial benefits