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NORTHERN BIOMEDICAL RESEARCH INC dbaNorthernB

QA Auditor I

NORTHERN BIOMEDICAL RESEARCH INC dbaNorthernB Norton Shores, Michigan, United States

Biotechnology Research · 201-500 employees

8 h ago
qa Mid (2-5 yrs) Full-time United States
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About the role

The QA Auditor will support Good Laboratory Practice (GLP) policies and represent the company during regulatory inspections. They are responsible for auditing study reports, maintaining the master schedule, and overseeing laboratory archives and computer system validation.

What they look for

Good Laboratory Practice GLP Quality Assurance Regulatory Inspections Computer System Validation 21 CFR Part 11 Audit Standard Operating Procedures Data Collection Regulatory Compliance Laboratory Archives Microsoft Office Risk Assessment Protocol Compliance

Requirements

Candidates should possess a bachelor's degree in a related discipline with 2-5 years of experience in GLP study support. Proficiency in Microsoft Office and a strong understanding of federal laboratory regulations are required.

Full description

  • 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 Northern Bio's Quality Assurance Unit (QAU). The Associate QA Auditor will represent Northern Bio during sponsor and regulatory inspections.

This is an exempt role with no Supervisor responsibilities.

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.

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