Senior Quality Assurance Specialist

2 weeks ago

Anand, Gujarat, India beBeeQuality Full time ₹ 9,00,000 - ₹ 12,00,000

Position Overview

We are currently seeking a skilled QA professional to provide ongoing clinical quality assurance (QA) support across multiple trials. This individual will play a key role in guiding cross-functional teams, maintaining compliance with Good Clinical Practice (GCP), and ensuring quality oversight.

Key Responsibilities

  • Serve as the primary QA resource for study teams, ensuring adherence to GCP and internal quality standards.
  • Provide QA expertise during team meetings, including:
  • Protocol deviation discussions
  • Risk-based quality management consultations
  • Study operations and trial oversight meetings
  • Develop, review, update, and format standard operating procedures (SOPs) and other quality documentation.
  • Manage and track quality processes within a quality management system, including document control, training, and CAPA management.
  • Address QA-related questions from study teams in real time, providing clear and actionable guidance.
  • Support inspection readiness and contribute to continuous improvement of QA systems and processes.
  • Collaborate with cross-functional stakeholders to align on quality expectations and risk mitigation.

Qualifications

  • Education: Bachelor's degree in life sciences, healthcare, or related field (advanced degree preferred).
  • Experience:
  • 5+ years of clinical quality assurance experience with a strong foundation in GCP.
  • Prior experience supporting study teams in a QA capacity.
  • Hands-on experience with a quality management system.
  • Technical Skills:
  • Proficient in Microsoft Office (Excel, PowerPoint, Word).
  • Skilled in technical writing, SOP development, and document formatting.
  • Soft Skills:
  • Excellent communication and interpersonal skills.
  • Strong organizational skills with the ability to work independently.
  • Availability: Must be available during Eastern or Mountain Time Zone working hours to participate in team meetings and provide timely QA support.

Contract Opportunity

This is a full-time contract position offering 30–40 hours per week of consistent work. The contractor will act as a core member of the QA function, providing essential support to ongoing clinical programs and ensuring regulatory compliance.

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