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Altasciences

Senior QA Auditor

Altasciences

. Carry out systematic and independent audits of study-related activities and documents .

Posted 9/15/2026full-timeColumbia • Missouri • United StatesSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in conducting systematic audits in compliance with GLP regulations, including proficiency in audit processes, documentation management, and regulatory interpretation. Capable of providing risk-based compliance guidance and supporting continuous process improvement initiatives.

Highest-signal resume keywords
GLP AuditingRegulatory ComplianceRisk-Based Compliance OpinionsSOP Review and QAProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Audit ProcessQuality AssuranceData Collection and AnalysisRegulatory InterpretationProcess Improvement
Soft Skills
CommunicationIndependent WorkProblem Solving
Tools & Technologies
Microsoft Office SuiteComputerized Audit Files
Certifications & Qualifications
RQAP-GLPASQ-CQA
Industry Keywords
GLPSOPsFDA RegulationsQuality TrendsVendor Qualifications

About the role

Key responsibilities & impact
  • Carry out systematic and independent audits of study-related activities and documents
  • Determine compliance with protocols, SOPs, GLP (21 CFR Part 58 and Part 11), and applicable regulatory requirements
  • Report findings to Study Directors, Responsible Persons, and Testing Facility Management
  • Audit nonclinical and laboratory study phases, reports, disciplines, facilities, vendors, equipment, and software validations
  • Perform in-life audits, process audits, vendor qualifications, facility audits, and validation audits
  • Act as lead auditor on studies and projects
  • Maintain computerized audit files, QA records, and study documentation
  • Support project planning and implementation
  • Provide risk-based compliance opinions and guidance
  • Write and issue inspection reports and evaluate responses to findings
  • Review SOPs and ensure they are current and practiced
  • Identify and communicate process improvement opportunities
  • Notify management of quality and compliance trends
  • Perform SOP QA reviews, client hosting, regulatory agency hosting, and external site qualifications
  • Interpret FDA regulations and regulatory guidance under supervision
  • Perform project management, quality issue investigations, and QA data collection, trending, and analysis under supervision
  • Recommend procedure modifications and support process improvement and resolution
  • Interpret and train staff on GLP and associated regulatory documents
  • Complete self-development efforts and assist with regulatory training

Requirements

What you’ll need
  • Bachelor degree or higher in a scientific discipline, or equivalent combination of education and experience
  • 2 - 3 years related technical experience and/or training
  • A minimum of two years auditing in a GLP-regulated environment
  • Professional certification such as RQAP-GLP or ASQ-CQA or other certification is recommended
  • Proficient with Microsoft Office Suite
  • Legally authorized to work in the United States
  • Must possess valid work authorization that does not require employer sponsorship now or in the future
  • On-the-job training in performing audits and inspections
  • Independent reading of professional articles, journals and internal SOPs
  • Continual GLP training

Benefits

Comp & perks
  • Health/Dental/Vision Insurance Plans
  • 401(k)/RRSP with Employer Match
  • Paid Vacation and Holidays
  • Paid Sick and Bereavement Leave
  • Employee Assistance & Telehealth Programs
  • Telework when applicable
  • Training & Development Programs
  • Employee Referral Bonus Program