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Senior QA Auditor
Altasciences. Carry out systematic and independent audits of study-related activities and documents .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
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
Tailor your resumeApplicant 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