QA Specialist I

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 looking for a Quality Assurance Specialist I to join a preclinical contract research organization (CRO) located in Rockville, MD.

Responsibilities of the Quality Assurance Specialist I include:

• 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

Qualifications for the Quality Assurance Specialist I include:

• 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

Compensation for Quality Assurance Specialist I includes:

• $25-$35/hr depending on experience
• Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law

This job is open for applications on September 21st, 2026. Applications will be accepted at least 30 days from the posting date.

Keywords:

GLP, Good Laboratory Practice, Quality Assurance, QA Audits, Raw Data Review, Study Protocols, Final Reports, Document Control, Records Management, Archives, Controlled Documents, SOP Authoring, SOP Review, Quality Systems Documentation, Regulatory Compliance, Scientific Documentation, Preclinical Research, In Vivo Studies, In Vitro Studies, Laboratory Compliance, CRO

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