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QA Consultant

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Proclinical

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Location:
United States , Durham

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

Lead GCP and QMS compliance from anywhere in the US as our expert QA Consultant. Proclinical is seeking a QA Consultant to support quality assurance activities within the pharmaceutical and oncology sectors. This is a remote, contract role with a focus on Good Clinical Practice (GCP) compliance and Quality Management Systems (QMS). The successful candidate will play a key role in ensuring adherence to quality standards and regulatory requirements while collaborating with cross-functional teams.

Job Responsibility:

  • Assist in establishing and maintaining the QA system in collaboration with the UK Team Lead
  • Manage compliance issues, including deviations, complaints, risk assessments, and CAPAs
  • Maintain accurate documentation of QMS activities
  • Oversee the review process for controlled documents
  • Collaborate with internal teams to drive continuous improvement of quality standards
  • Support risk-based internal audits and manage supplier audits to ensure compliance
  • Assist with external client audits and regulatory inspections

Requirements:

  • Strong knowledge of GCP regulations and ISO standards
  • Proficiency in Quality Management Systems (QMS)
  • Excellent communication and influencing skills for engaging stakeholders
  • Strong problem-solving, risk assessment, and CAPA management abilities
  • Experience in Quality Assurance, GCP compliance, or risk-based auditing within the pharmaceutical or biotech industry
  • Hands-on experience with internal audits, supplier audits, and regulatory inspections
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
  • Degree in a relevant field such as Life Sciences, Quality Management, or Regulatory Compliance

Nice to have:

Familiarity with Ideagen Q-Pulse tool is a plus

Additional Information:

Job Posted:
February 19, 2026

Work Type:
Remote work
Job Link Share:

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