QA Auditor I - GLP & Preclinical Compliance

Piper Companies; Rockville (MD); On-site; USD 34,000 - 43,000; 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 CRO in Rockville, MD. The role focuses on GLP audits of data, protocols and final reports, with responsibility to report findings to study directors and QA leadership.

Ideal candidates hold an AS/BS in Biological or Regulatory Sciences with 1+ year in a regulated lab; GLP experience is preferred. Excellent communication and independent work skills are valued in a fast-paced onsite setting.

Qualifications

• AS or BS degree in Biological Sciences, Regulatory Sciences, or related field; 1+ year in a regulated environment preferred.
• GLP experience is preferred.
• Ability to review scientific documentation and communicate audit findings.

Responsibilities

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

Skills

GLP experience

Audit findings communication

Regulatory compliance knowledge

Independent work

Education

AS or BS degree in Biological Sciences or Regulatory Sciences

Job description

Piper Companies is seeking a Quality Assurance Specialist I to join a preclinical CRO in Rockville, MD. The role focuses on GLP audits of data, protocols and final reports, with responsibility to report findings to study directors and QA leadership.

Ideal candidates hold an AS/BS in Biological or Regulatory Sciences with 1+ year in a regulated lab; GLP experience is preferred. Excellent communication and independent work skills are valued in a fast-paced onsite setting.