QA Specialist I - 174844

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 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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