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We are searching for Quality Control Analysts at several levels, for a trusted drug development and manufacturing CDMO in the Bay Area to perform microbiological testing and environmental monitoring of clinical manufacturing process samples. 
 
Requirements for the Quality Control Analyst:
 
  • Bachelor’s Science in a related field and minimum
  • 2-8 years QC experience in a cGMP environment
  • Understanding of relevant regulatory guidelines including FDA, EU, ICH, USP
  • Strong knowledge of contamination control principals, method development and qualifications
  • Ability to exercise excellent quality control judgement and assess and resolve complex issues effectively.
  • Ability to manage multiple projects and work cross functionally and collaboratively in a dynamic, fast paced environment.
  • Experience with risk management.
  • Excellent verbal and written communication skills.
 
Responsibilities of the Quality Control Analyst:
 
  • Coordinate and execute environmental and critical utility monitoring program for the manufacturing site.
  • Utilize Bioburden, Conductivity, TOC, and Endotoxin per USP guidelines for microbiological testing.
  • Conduct technical assessments and investigate deviations.
  • Conduct routine trend analysis of environmental monitoring data and prepare trend reports.
  • Develop, implement and maintain general laboratory operational systems in accordance with cGMP requirements.
  • Write SOPs, technical protocols and reports and revise as needed.
  • Collaborate with the quality control management team to ensure the quality, compliance and efficiency of QC operations.
  • Ensure a safe laboratory working environment.
  • Ensure contamination control principals literature and technologies remain current and up-to-date.
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