Clinical Quality Assurance Consultant

QA Consultant - Contract - Remote USA

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).

Primary Responsibilities:

The successful candidate will play a key role in ensuring adherence to quality standards and regulatory requirements while collaborating with cross-functional teams.

Skills & Requirements:

• Strong knowledge of GCP regulations and ISO standards.
• Proficiency in Quality Management Systems (QMS).
• Familiarity with Ideagen Q-Pulse tool is a plus.
• 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.

The QA Consultant's responsibilities will be:

• 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.

If you are having difficulty in applying or if you have any questions, please contact Alex Bill at

a.bill@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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