QA Auditor I — GLP Compliance & Audits

Piper Companies; Rockville (MD); On-site; USD 34,000 - 48,000; Full time

Benefits offered by this job

Medical/Dental/Vision

401K

Sick Leave

Job summary

Piper Companies is seeking a Quality Assurance Specialist I to join a preclinical contract research organization (CRO) in Rockville, MD. The role focuses on GLP-compliant audits of raw data, study protocols, final reports, and related QA documentation to ensure regulatory readiness.

The candidate will report audit findings to Study Directors, maintain QA records, and support regulatory inspections and SOP management.

Qualifications

• AS or BS degree in Biological Sciences, Regulatory Sciences, or a related field with at least 1 year of technical or quality experience
• Experience in a regulated laboratory environment; GLP experience preferred
• Ability to review scientific documentation, communicate audit findings, and work independently or within a team environment

Responsibilities

• Perform raw data, critical study phase, facility, study protocol, and final report audits in accordance with GLP requirements
• Report audit and inspection findings to Study Directors and Testing Facility Management
• Maintain quality assurance records, audit status reports, study protocols, amendments, and related QA documentation
• Assist with regulatory inspections, site visit preparation, document control, archival activities, and SOP management

Skills

Audit readiness

Communication

Independent work

Education

AS/BS in Biological Sciences or Regulatory Sciences

Job description

Piper Companies is seeking a Quality Assurance Specialist I to join a preclinical contract research organization (CRO) in Rockville, MD. The role focuses on GLP-compliant audits of raw data, study protocols, final reports, and related QA documentation to ensure regulatory readiness.

The candidate will report audit findings to Study Directors, maintain QA records, and support regulatory inspections and SOP management.