QA Specialist I - 174844

Zachary Piper Solutions

Rockville (MD)

On-site

USD 71,635,000 - 89,544,000

Full time

7 days ago
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Benefits offered by this job

Cigna Medical/Dental/Vision
401K
Sick Leave

Job summary

Piper Companies in Rockville, MD is seeking a Quality Assurance Specialist I for a preclinical CRO. You will perform GLP audits of raw data, study protocols, and final reports, and report findings to Study Directors and facility management.

You will maintain QA records, assist with regulatory inspections, document control, archiving, and SOP management as part of a collaborative QA team. A foundational degree and GLP exposure are encouraged.

Qualifications

  • GLP experience preferred
  • Experience in a regulated laboratory environment
  • Ability to review scientific documentation and communicate audit findings

Responsibilities

  • Perform audits of raw data, critical study phase, facility, study protocol and final report per GLP requirements
  • 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 knowledge
Audit ability
Documentation

Education

AS or BS in Biological/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-$31.25/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 30th, 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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