- 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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