About this role

Role Summary

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

Role Responsibilities

✓Assure management that GLP, Clinical, and Method Validation 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 as required.
✓Audit In-process phases of GLP studies, Clinical Studies, and Method Validations, as applicable.
✓Audit study reports for GLP, Clinical, and Method Validation studies to ensure the raw data is represented accurately.
✓Act as lead QA in a multi-site study.
✓Maintain Master Schedule.
✓Assist/conduct the annual Facility Audit.
✓Conduct Process Based Audits.
✓Review Standard Operating Procedures as applicable.
✓Interact with regulatory agencies and sponsors during inspections and audits of Northern Bio’s facility.
✓May assist with QA oversite of Computer System Validation and 21 CFR Part 11 Compliance.
✓May assist in training Northern Bio employees in GLP regulations as needed.
✓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 a lead or consult for process improvement or CAPA projects.
✓May act as Archivist or Backup Archivist
✓Maintain the archives database to include but not limited to placing materials in archive and retrieving materials from archive as needed.
✓Monitor the protocol specified archive storage requirements and contact the sponsor when these requirements have been met to determine final disposition of the study material.
✓Manage offsite archives.
✓Contact and coordinate with Sponsors for return of study materials.
✓Other duties as assigned.

Role Requirements

✓Bachelor’s degree in a related discipline.
✓> 3 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 the day standing and/or walking.