Associate Scientist, QCA - PM Shift

Novartis • Morris Plains, NJ

36d • Onsite

About The Position

Under general direction, perform testing and other activities in functions supporting the Quality Control department (QC Bioassay). Location: This position is on-site in Morris Plains, NJ #LI-Onsite PM Shift: 12-hour 4/3 shift (alternates every other week) Please only apply if you are able to work these exact hours. Week 1: Wednesday-Saturday, 3:30 PM-3:30 AM Week 2: Thursday-Saturday, 3:30 PM-3:30 AM Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Requirements

• BA or MS in chemistry, biochemistry, microbiology or other related science.
• Fluent in English.
• 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 bioassay 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 interpersonal skills which include a professional demeanor when interacting with Novartis personnel.
• Sound, practical and appropriate regulations with regards to Novartis
• Strong written and verbal communication skills are essential.
• Thorough understanding of cGMP requirements
• Good communication and organizational skills
• Ensure customer satisfaction and react to customer requests
• Is seen as a competent team player
• Strong ability to work independently, compliantly and results driven
• Strong analysis and decision-making skills surrounding documentation
• Attention to detail
• Able to proof work and identify non-standard format or wording, and errors within documents

Responsibilities

• Perform Bio-Analytical testing such as qPCR, Flow Cytometry, ELISA, cell count, cell viability, sterility testing, endotoxin, and mycoplasma.
• Maintain controls and reference standards to support testing.
• Follows quality policies.
• Plan and schedule assigned activities.
• 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.
• Support 5S and Lean projects.
• Identify potential improvements in project work.
• Interface with regulatory agencies during audits.
• Contribute to assigned projects.
• Knowledge of LabWare LIMS and/or other QC data systems.
• Maintain GMP/GLP quality systems.
• In addition to these primary duties, provide coverage for all appropriate areas and testing.
• Performs other job duties as assigned.

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees