QA Auditor (GLP/ GCP)

Champion Quality. Protect Data Integrity. Enable Scientific Excellence.

Are you passionate about quality, compliance, and ensuring that scientific data can stand up to the highest regulatory scrutiny? We are seeking a QA Auditor (I, II, or III) to join our growing Quality Assurance team and play a critical role in supporting GLP and GCP-regulated studies.

In this position, you will partner closely with laboratory operations, scientific teams, and leadership to ensure data integrity, regulatory compliance, and operational excellence. You'll have the opportunity to conduct meaningful audits, identify process improvements, influence quality culture, and help ensure that critical scientific work meets the highest industry standards.

Whether you're building your auditing career or bringing advanced QA expertise, this role offers the opportunity to make a visible impact while working in a collaborative, science-driven environment.

Responsibilities

Core Responsibilities (QA Auditor I, II & III)

• Conduct audits of study documentation, laboratory records, and quality systems to ensure compliance with GLP, GCP, GDP, and applicable regulatory requirements.
• Review laboratory notebooks, study plans, sample runs, chromatograms, instrument logs, and supporting documentation for accuracy, completeness, and adherence to SOPs.
• Audit data files, reports, and electronic records to verify data integrity and regulatory compliance.
• Evaluate computer systems, laboratory operations, facility processes, and other regulated activities.
• Review audit trails and electronic systems to support compliance and data integrity initiatives.
• Monitor adherence to Good Documentation Practices (GDP) and established quality standards.
• Identify compliance gaps, deviations, quality events, and process risks while supporting timely resolution.
• Escalate significant compliance and data integrity concerns to leadership as appropriate.
• Support maintenance of the Quality Assurance Master Schedule.
• Assist with the review of templates, forms, procedures, and Standard Operating Procedures (SOPs).
• Participate in client, sponsor, and regulatory audits as needed.
• Promote a culture of quality by providing guidance on SOPs, compliance requirements, and quality expectations.
• Support continuous improvement initiatives and other quality-related projects.

Additional Responsibilities (QA Auditor II & III)

• Deliver quality and compliance training to laboratory and operational teams.
• Develop, track, analyze, and present quality metrics and trending data.
• Conduct vendor qualifications, assessments, and supplier audits.
• Mentor and train junior auditors, providing technical and regulatory guidance.
• Drive process improvements that enhance quality, efficiency, and regulatory readiness.
• Participate in investigations, root-cause analyses, CAPAs, and quality event management.
• Author, review, and revise SOPs, templates, and controlled quality documents.
• Serve as a trusted quality partner and subject matter resource across the organization.

Skills, Education & Qualifications

Required Qualifications

• Bachelor's degree in a scientific discipline or related field; advanced degrees and equivalent experience are welcome.
• 1–7 years of experience in a regulated GxP environment. Experience level will determine placement as Auditor I, II, or III.
• Working knowledge of GLP, GCP, GDP, and electronic record requirements, including 21 CFR Part 11.
• Strong attention to detail and ability to review complex scientific, technical, and quality documentation.
• Excellent written and verbal communication skills.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Proficiency with computer systems and electronic quality documentation.
• Ability to work independently while collaborating effectively across teams.

Preferred Qualifications

• Experience within pharmaceutical, biotechnology, CRO, life sciences, or regulated laboratory environments.
• Experience conducting internal audits, vendor audits, or quality system assessments.
• Familiarity with quality event management, investigations, and CAPA processes.
• Demonstrated ability to identify risks and recommend practical, compliant solutions.
• Experience mentoring, training, or leading quality initiatives (Auditor II/III).

Why Join Us?

• Be part of a team that helps ensure the integrity and reliability of critical scientific data.
• Work alongside talented scientists, operational leaders, and quality professionals.
• Influence quality culture and drive continuous improvement initiatives.
• Gain exposure to diverse GLP and GCP-regulated studies and quality systems.
• Expand your expertise through professional development and career growth opportunities.
• Make a meaningful impact by helping advance high-quality science and regulatory excellence.