QA Auditor II

• Support all Good Laboratory Practice (GLP) policies, including FDA, OECD, and MHLW requirements, for Northern Bio’s Quality Assurance Unit
• Assure management that GLP, Clinical, and Method Validation studies comply with protocol-specified regulations and have sufficient documentation
• Audit protocols and amendments
• Audit in-process phases of GLP studies, Clinical Studies, and Method Validations
• Audit study reports to ensure raw data is represented accurately
• Act as lead QA in multi-site studies
• Maintain the Master Schedule
• Assist with or conduct the annual Facility Audit
• Conduct Process Based Audits
• Review Standard Operating Procedures
• Interact with regulatory agencies and sponsors during inspections and audits
• Assist with QA oversight of Computer System Validation and 21 CFR Part 11 compliance
• Assist with training employees in GLP regulations
• Assist with supplier qualifications through remote or off-site inspections
• Assist with tracking and trending deviations and audit findings
• Lead or consult on process improvement or CAPA projects
• Act as Archivist or Backup Archivist
• Maintain the archives database, including placing and retrieving materials
• Monitor protocol-specified archive storage requirements and coordinate final disposition with sponsors
• Manage offsite archives
• Coordinate with sponsors regarding return of study materials
• Perform other duties as assigned

• Bachelor’s degree in a related discipline
• More than 3 years of QA support of GLP studies preferred
• RQAP certification from SQA preferred
• Proficiency with Microsoft Office core applications and 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
• Ability to multitask
• Collaboration
• Flexibility
• Ability to don and wear personal protective gear, including N95 masks and respirators
• Ability to spend part of the day standing and/or walking

Demonstrates expertise in Good Laboratory Practice (GLP) compliance, including FDA, OECD, and MHLW regulations, with a strong focus on quality assurance in clinical and method validation studies. Proficient in auditing processes, managing documentation, and ensuring adherence to regulatory standards.

• GLP Compliance
• Quality Assurance (QA)
• Computer System Validation
• RQAP Certification
• Audit Management

• GLP Regulations
• Method Validation
• Audit Protocols
• Data Collection
• Study Protocols
• Process Improvement
• Deviation Tracking
• Standard Operating Procedures (SOPs)
• 21 CFR Part 11 Compliance
• Facility Audits

• Effective Communication
• Self-Motivation
• Multitasking
• Collaboration
• Flexibility

• RQAP Certification

• Good Laboratory Practice (GLP)
• FDA
• OECD
• MHLW
• Clinical Studies
• Quality Assurance Unit
• Process Based Audits
• Supplier Qualifications
• Regulatory Agencies
• Laboratory Sciences

• Microsoft Office
• Archives Database