Position Details

Type Not Specified

Experience mid

Exp. Years Not specified

Education Not specified

Category QA & Testing

About this role

GCP Quality Assurance Auditor in Bethesda; supports QA programs, document control, CAPA, and audits of clinical sites and vendors; supports internal audits and regulatory agency audits within a CRO environment.

Key Responsibilities

Maintain the Quality Management System
Maintain the QA training program and document control
Support audits of clinical sites and vendors
Support internal audit program and performance metrics
Manage review cycle of QA controlled documents

Technical Overview

Quality assurance framework in clinical research with emphasis on GCP compliance, CAPA, and documentation; interaction with regulatory bodies and CROs; MS Office proficiency.

Ideal Candidate

The ideal candidate is a QA auditor with strong GCP knowledge and CRO experience; proficient in regulatory audits, CAPA, and QA documentation control; excellent written and verbal communication with MS Office proficiency.

Must-Have Skills

Knowledge of current GCP regulationsExperience with regulatory agency auditsExperience with Quality Systems for CROsExcellent written/verbal communication skills

Nice-to-Have Skills

Experience with CROsCAPA managementClinical research QA

Tools & Platforms

MS OfficeQuality Management System

Required Skills

GCP regulationsregulatory agency auditsQuality Systems for CROsCAPAdocument controlQuality Management SystemQA training programMS Officeregulatory auditsinternal auditaudits of clinical sitesvendor auditsclinical research

Hard Skills

GCPGood Clinical PracticeGCP regulationsregulatory agency auditsQuality Systems for CROsCAPAdocument controlQuality Management SystemQA training programMS Officeregulatory audits

Soft Skills

written/verbal communicationattention to detailorganizationproblem solving

Industry & Role

Industry Healthcare & Medical

Job Function Quality assurance auditing and regulatory compliance support for clinical research under GCP

Role Subtype Quality Assurance

Tech Domains Microsoft Office, Quality Management System, CAPA

Keywords for Your Resume

gcpgood clinical practicegcp regulationsregulatory agency auditsquality systems for croscapadocument controlqa training programquality management systeminternal auditaudits of clinical sitesvendor auditsclinical researchms officeregulatory auditsGCPGood Clinical PracticeCROsCAPAMS OfficeQA training

Deal Breakers

No GCP knowledge, No regulatory audits experience, No CRO experience

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