Quality Assurance Auditor I: GLP & Preclinical QA

ZP Group; Rockville (MD); On-site; USD 34,000 - 43,000; Full time

Benefits offered by this job

Cigna Medical/Dental/Vision

401K

Sick Leave as Required by Law

Job summary

Piper Companies seeks a Quality Assurance Specialist I for its preclinical CRO in Rockville, MD. The role audits data, study protocols, and reports to QA and facility management, ensuring GLP compliance.

You will assist with inspections, document control, SOPs, and QA records, contributing to quality systems in a fast-paced environment. The ideal candidate holds AS or BS in Biological/Regulatory sciences with 1 year in a regulated lab and GLP exposure, and can communicate audit findings

Qualifications

• GLP experience in a regulated lab environment.
• Ability to review scientific documentation and communicate audit findings.
• Strong independence and teamwork capabilities.

Responsibilities

• Perform audits of raw data, critical study phase data, facility, study protocols, and final reports per GLP.
• Report audit findings to Study Directors and Testing Facility Management.
• Maintain QA records, audit status reports, study protocols, amendments, and related QA documents.
• Assist with regulatory inspections, site visit prep, document control, archival activities, and SOP management.

Skills

GLP experience

Audit

Documentation review

Regulatory compliance

Education

AS/BS in Biological or Regulatory Sciences

Job description

Piper Companies seeks a Quality Assurance Specialist I for its preclinical CRO in Rockville, MD. The role audits data, study protocols, and reports to QA and facility management, ensuring GLP compliance.

You will assist with inspections, document control, SOPs, and QA records, contributing to quality systems in a fast-paced environment. The ideal candidate holds AS or BS in Biological/Regulatory sciences with 1 year in a regulated lab and GLP exposure, and can communicate audit findings