Microbiologist I

BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Animal Care Tech to work for a leading San Diego biotechnology company.


Microbiologist I


Summary:
Be a lead in a cGMP working environment with cleanroom experience dealing with environmental monitoring, sterility testing and endotoxin testing and microbiological trends. Conducts product performance and compounding process investigations, experiments, studies, and tests related to sterility assurance and aseptic controls in compliance with Standard Operating Procedures (SOPs) & Regulatory Standards. Prepare and present technical microbiology and sterility assurance investigative and reports to management. Formulate microbiology or sterility assurance recommendations for disposition or other actions related to product non-conformances, process deviation, product complaints investigations. Recommend and implement continuous microbiological quality improvements. 

Responsibilities:
  • Knowledge and ability to work in a cGMP environment in a FDA MFG setting. 
  • Conducts product performance and compounding process investigations, experiments, studies, and tests related to sterility assurance and aseptic controls. 
  • Prepare and present technical microbiology and sterility assurance investigative and trend reports to management. 
  • Formulate microbiology or sterility assurance recommendations for disposition or other actions related to product non-conformances, process deviation, product complaints investigations. 
  • Lead micro team and help with ensuring responsibilities of the micro department are met 
  • Perform, lead, and schedule routine analysis of finished product, raw material or environmental samples according to established specifications and procedures using various laboratory apparatus, as necessary 
  • Performs technical review of test results for completeness and compliance to cGMP’s to ensure that excellent documentation, controls and traceability are in place to maintain integrity. 
  • Interprets and applies specifications and operating procedures when carrying out and reviewing testing responsibilities. 
  • Proficient in micro testing i.e. Sterility testing, LAL. 
  • Proficient in Environmental Monitoring techniques. 
  • Understand and Microbial Identification techniques 
  • Understands and demonstrates aseptic technique with experience with cleanroom environment preferred. 
  • Support Internal (RC, Third Party Consultants) & External audits by regulatory agencies, such as FDA and CaBOP 

Requirements:
  • B.S. degree in Microbiology, or equivalent experience 
  • 3 – 5 years’ experience in Pharmaceutical / medical device industry 
  • Valid driver’s license required 
  • Knowledge of good analytical and laboratory techniques, cGMP’s, USP and FDA requirements 
  • Good analytical, writing, interpersonal, and organizational skills 
  • Ability to meet deadlines 
  • Must be able to work independently 
  • Strong communication skills 
  • Ability to demonstrate leadership skills 
  • Must be detail oriented and have multi-tasking capabilities with ability to prioritize. 


  • Location: San Diego
  • Type: Contract
  • Job ID: RH138593105