QC Microbiologist in Santa Monica, CA at Apex Life Sciences

Date Posted: 3/5/2018

Job Snapshot

Job Description

A well-regarded company focusing on patient therapies is seeking a QC Microbiologist to join their team. This is a great opportunity to work for an industry leader!

Responsibilities (include but are not limited to):

  • Conduct QC Micro laboratory testing  (Sterility, Endotoxin and Gramstain)
  • Handle sample receipt, retain storage and disposal
  • Perform environmental monitoring program for Kite
  • Manage Aseptic gowning training and qualification program
  • Conduct  QC Microbiology training program
  • Work with QC raw materials team to establish specifications and testing process of raw materials.
  • SME on investigations of Microbiological assays and environmental excursions
  • Monitor and trend data
  • Assemble reports on findings from environmental monitoring of cGMP facility. Implement corrective action plans when necessary
  • Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
  • Develop, revise and review SOPs, qualification/validation protocols and reports
  • Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures  
  • Provide updates at daily and weekly meetings
  • Monitor the GMP systems currently in place to ensure compliance with documented policies
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
  • Gather metric information for use in continuous improvement of areas of responsibility
  • Other duties as assigned


  • Bachelor's degree or advanced degree in Microbiology or related discipline
  • A minimum of 5-7 years’ experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required.
  • The ideal candidate is well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to product
  • Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes
  • The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
  • Quality Control, GMPs, microbiological method development and validation
  • Strong knowledge of GMP, SOPs and quality control processes
  • Strong data integrity knowledge and practices.
  • Strong knowledge of aseptic manufacturing and EM processes
  • Proficient in MS Word, Excel, Power Point and other applications
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.