QA Auditor I

Role Summary

The Associate Quality Assurance (QA) Auditor will be engaged in supporting all Good Laboratory Practice (GLP) policies (includes FDA, OECD, and MHLW) for the purpose, function, and execution of NBS’s Quality Assurance Unit (QAU). The Associate QA Auditor will represent NBS during sponsor and regulatory inspections.

This is a full-time exempt role with no supervisory responsibilities and reports to the QA Manager.

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 in-life phases of GLP studies
• Audit study reports for GLPs to ensure the raw data represented accurately
• Act as lead QA in a multi-site study
• Maintain Master Schedule
• Conduct Annual Facility Audit
• Conduct Process Based Audits
• Review NBS Standard Operating Procedures
• Train NBS employees in GLP regulations as needed
• Provide QA oversite of Computer System Validation and 21 CFR Part 11 Compliance
• Oversee the responsibilities of any QA Technicians at NBS or outside QA consultants supporting NBS studies
• Perform off-site Subcontractor Inspections
• Interact with regulatory agencies and customers during inspections and audits of NBS’s facility
• Responsible for maintaining the laboratory archives
• Other duties as assigned

Role Requirements

• Bachelor’s degree in a related discipline with 2-5 years of QA support of GLP studies preferred
• RQAP certification from SQA preferred.
• Proficiency with Microsoft Office core applications and the ability to learn and use additional applications.
• Knowledge of GLPs and other federal regulations relating to laboratory sciences
• Experience with Computer System Validation and 21 CFR Part 11
• Good understanding of study protocols
• Good understanding of laboratory operations and data collection
• Ability to work effectively under time constraints
• Good written and oral communication skills
• Self-motivated and able to prioritize work

Behavioral Expectations

• Ability to multitask
• Collaboration
• Flexibility

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.