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Clinical Research QA Specialist
Clinical Research QA SpecialistPiper Companies • Bethesda, MD
Clinical Research QA Specialist

Clinical Research QA Specialist

Piper Companies • Bethesda, MD
[job_card.30_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Job Description:

Piper Companies is seeking a QA Specialist that’s well-versed in Infor to join a rapidly growing organization based in a hybrid capacity in Bethesda, MD.

Responsibilities for the QA Specialist include:

  • Acts as a Subject Matter Expert (SME) for quality.
  • Enhances quality by reviewing work instructions, training staff, and supporting the Quality Management System.
  • Facilitates client audits, conducts external audits at clinical and vendor sites, and leads process improvement activities and CAPA investigations.
  • Performs clinical site audits (both domestic and international) to ensure regulatory and protocol compliance.
  • Ensures clinical compliance with applicable Standard Operating Procedures (SOPs) and regulations.
  • Reviews clinical audit reports and provides guidance to auditors.
  • Supports the inspection readiness program.

Qualifications for the QA Specialist include:

  • Bachelors degree and minimum five years’ of GCP auditing experience.
  • Demonstrated eQMS and MS Office experience
  • Travel: % Local, Domestic, and International (NIH, Mid-west, California, Amsterdam,)
  • Certified Quality Auditor (CQA) preferred

Compensation for the QA Specialist includes:

  • Salary Range: $,-$, **depending on experience*
  • Full Benefits: Healthcare, Dental, Vision, k, Paid Time Off, and Sick Leave (if required by law)

This job opens for applications on //. Applications for this job will be accepted for at least days from the posting date.

Keywords:

QA, quality assurance, testing, quality assurance tester, test planning, manual testing, automated testing, bug tracking, GCP, Contract, analyst, healthcare, management, manager, regression, performance testing, functional testing, user acceptance testing, reliability, performance, cross browser, SQL, data, database, database testing, agile, scrum, waterfall, senior, communication, execution, software, maryland, red hat linux, redhat

#LI-SF1 #LI-HYBRID #pando #LI-DNP

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Clinical Research QA Specialist • Bethesda, MD

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