What are the responsibilities and job description for the Senior QA Auditor position at Northern Biomedical Research Inc?
Job Description
Job Description
We are Hiring!
Role Summary
The Senior Quality Assurance (QA) Auditor will engage in supporting all Good Laboratory Practice (GLP) policies (includes FDA, OECD, and MHLW) for the purpose, function, and execution of Northern Biomedical Resources (NBR’s) Quality Assurance Unit (QAU).
This is an exempt role with no supervisory responsibility.
Role Responsibilities
- Assure management that GLP studies are conducted in a manner that conforms to all protocol-specified regulations and that there is sufficient documentation to support all findings of the study.
- Audit Protocols and Amendments of GLP and / or Method Validation Studies
- Audit in-process phases of GLP and / or Method Validation studies
- Audit study reports for GLP and / or Method Validation studies
- Act as lead QA in a multi-site study
- Maintain Master Schedule
- Conduct the Annual Facility Audit
- Conduct Process Based Audits
- Review Standard Operating Procedures
- Provide regulatory training as needed
- Interact with or host regulatory agencies and auditors during inspections and audits
- May assist with supplier qualifications, either via remote or off-site inspections
- May assist with tracking and trending of deviations and audit findings
- May act as lead or consult for process improvement or CAPA projects
- May assist in review or consultation for CSV activities
- May serve as the backup archivist
- Other duties as assigned
Role Requirements
Behavioral Expectations
Special Requirements
