Description

Position Summary 

Kashiv BioSciences A fully-integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for an experienced Microbiologist to join our South Plainfield/Piscataway, NJ Quality Control team.? 

This candidate works closely with Management on department strategy and work projects. Fills in as Microbiologist Subject Matter Expert (SME) when Management is not available. Schedules microbiological testing, release of product and testing for validation protocols 

Essential Duties & Responsibilities 

• Coordinates microbiological testing, release of product and testing for validation protocols. 
• Performs organism identification. 
• Performs technical review of batch filling records to ensure quality of aseptic processes. 
• Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests.
• May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives. 
• Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness. 
• Performs other functions as required or assigned.
• Complies with all company policies and standards.

Requirements

Position Requirements and Qualifications

Education: 

BS or MS in a scientific discipline or equivalent and a minimum 3-8 years related experience. Expert knowledge of scientific principles and concepts. 

Special Skills: 

• Other special projects and/or duties may be assigned by Management. 
• Trains other Microbiologist on Department methods, process and procedure 
• Works with other departments to accomplish Company goals or projects. 
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. 
• Ability to write routine reports and/or correspondence. 
• Ability to speak effectively before groups or employees of organization.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.