• Work with the test facility manager to implement the quality management system for the GLP bioanalysis organization.
  • Provide comprehensive support in quality assurance, such as establishing Standard Operating Procedures (SOPs), reviewing study plans, auditing studies, issuing Quality Assurance (QA) statements.
  • Perform QA audits, inspections (internal/external), and monitoring procedures against standard operating procedures, methods, protocols/plans, guidance, and/or regulations, as applicable.
  • Hosting client and regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as required.
  • Active participation and identification of compliance gaps to ensure that the organization and studies are conducted in compliance with pertaining regulatory authorities.



  • Bachelor’s degree in biology, chemistry, biochemistry or a related field and a minimum of 5 years of experience in the field or in a related field.
  • Minimum of 2-year experience working in an environment subject to FDA GLP regulations.
  • Experience in biologics bioanalysis is a plus.



  • GLP auditing experience in the quantitative analytical facility. Experience working with large molecule bioanalysis work (PK/ADA, Watson LIMs software) is highly desired.
  • Ability to work in a fast-paced environment where multiple projects are in process and must be completed in a timely manner.
  • Excellent oral and written communication skills


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