Laboratory Quality Auditor

Applied Medical•Rancho Santa Margarita, CA

3d•Onsite

About The Position

The Quality Auditor supports compliance, audit readiness, and continuous improvement at Applied Medical by planning, executing, and reporting on internal audits, supplier audits, and external regulatory inspections. This role operates within a laboratory quality assurance environment and ensures compliance with ISO/IEC 17025:2017, FDA Good Laboratory Practice (GLP) regulations under 21 CFR Part 58, and applicable internal procedures. Candidates with a background in laboratory quality assurance, internal auditing, regulatory compliance, or GLP-regulated environments are encouraged to apply.

Requirements

Bachelor's degree in biology, microbiology, chemistry, or a related field; or equivalent experience in a regulated industry environment.
Familiarity with quality systems and the ability to interpret and assess compliance with regulatory requirements in laboratory environments.
Ability to conduct independent, risk-based audits and inspections with a high degree of objectivity and professional judgment.
Strong written and verbal communication skills for audit reporting and interaction with regulatory and accreditation bodies.
High attention to detail with the ability to assess laboratory data integrity, record-keeping practices, and electronic systems.
Proficiency with Microsoft Office Suite, SAP, and Adobe Suite.
Ability to read, write, and speak English; comprehend work and safety instructions; and communicate effectively across teams.
Ability to work comfortably in laboratory and controlled environments.

Nice To Haves

Knowledge of ISO/IEC 17025:2017 and FDA GLP regulations under 21 CFR Part 58.
Previous experience in laboratory quality assurance, internal auditing, or supporting external audits, supplier audits, or GLP-regulated environments.
Training in auditing techniques and quality management systems.

Responsibilities

Develop and maintain the annual internal audit schedule aligned with ISO/IEC 17025 and GLP requirements.
Conduct independent internal audits of laboratory management and technical activities, supplier audits, and support external audits and regulatory inspections including those conducted by ANAB and the FDA.
Maintain audit records, inspection reports, and objective evidence in accordance with document and record control procedures.
Perform GLP study phase inspections, including protocol, in-life, data, and report phases, to ensure compliance with 21 CFR Part 58.
Verify the effectiveness of corrective actions through follow-up audits and documented effectiveness checks.
Review and approve GLP-controlled documents including protocols, standard operating procedures (SOPs), amendments, and final reports.
Ensure the Quality Assurance Unit (QAU) maintains independence from study conduct and laboratory operations, and report inspection findings directly to laboratory management and the Study Director as applicable.
Analyze audit trends and systemic risks, and deliver clear, actionable audit reports to support risk-based quality oversight.
Collaborate with laboratory management, quality teams, Study Directors, suppliers, and external regulatory or accreditation bodies during audits and inspections.