QA Specialist

2 days ago

Rajahmundry, Andhra Pradesh, India K3-Innovations, Inc. Full time

Commitment: Full-Time Contract (30–40 hours per week)

Location: Based in India, Remote – Eastern Time Zone (preferred) or Mountain Time Zone

Reports To: Clinical QA Lead / Director of Quality

Position Overview

We are seeking an experienced QA Specialist / Manager-level contractor to provide day-to-day clinical quality assurance (QA) support across ongoing clinical trials. This individual will play a key role in guiding study teams, maintaining compliance with Good Clinical Practice (GCP), and ensuring quality oversight. The ideal candidate brings strong experience with Veeva QMS, is highly tech-savvy, and can support clinical operations teams in a fast-paced, remote environment.

Key Responsibilities

  • Serve as the primary QA support resource for clinical study teams, ensuring compliance with GCP and internal quality standards.
  • Provide QA expertise during study calls, including:
  • Protocol deviation meetings
  • Risk-based quality management discussions
  • Study operations and trial oversight meetings
  • Write, review, update, and format standard operating procedures (SOPs) and other quality documentation.
  • Manage and track quality processes within Veeva QMS, 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.
  • Partner with cross-functional stakeholders (Clinical Operations, Data Management, Regulatory, etc.) to align on quality expectations and risk mitigation.

Qualifications

  • Education: Bachelor's degree in life sciences, healthcare, or related discipline (advanced degree preferred).
  • Experience:
  • 5+ years of Clinical Quality Assurance experience with a strong foundation in GCP.
  • Prior experience supporting clinical study teams in a QA capacity.
  • Hands-on experience with Veeva QMS.
  • Technical Skills:
  • Proficient in MS Office (Excel, PowerPoint, Word).
  • Skilled in technical writing, SOP drafting, 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 attend study calls and provide timely QA support.

Contract Opportunity

This is a full-time contract role 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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