Senior QA Auditor

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

• Minimum: BS equivalent in animal or life science related discipline.
• 5+ yrs of Quality Assurance support of preclinical GLP studies preferred
• RQAP certification from SQA preferred
• Proficiency with Microsoft Office core applications and the ability to learn and use additional applications.
• Excellent written and oral communication skills
• Excellent understanding of study protocols
• Knowledge of GLPs and other relevant federal regulations
• Strong understanding of laboratory operations and data collection
• Ability to work effectively under time constraints

Behavioral Expectations

• Time Management
• Collaboration
• Critical Thinking

Special Requirements

• The person filling this position will spend approximately 80% in an office setting and 20% in the laboratory. There will be exposure to animal pathogens and chemicals. There will be exposure to animal tissue and zoonotic organisms.
• Ability to don and wear personal protective gear, including N95 masks and respirators.
• Ability to spend part of day standing and/or walking.
• Ability to work beyond typical work schedule including but not limited to evenings, weekends, extended shifts with short notice.