QA Specialist

4 days ago

Delhi, 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 ZoneReports To:Clinical QA Lead / Director of QualityPosition OverviewWe are seeking an experiencedQA Specialist / Manager-level contractorto 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 withGood Clinical Practice (GCP) , and ensuring quality oversight. The ideal candidate brings strong experience withVeeva QMS , is highly tech-savvy, and can support clinical operations teams in a fast-paced, remote environment.Key ResponsibilitiesServe 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 meetingsRisk-based quality management discussionsStudy operations and trial oversight meetingsWrite, review, update, and formatstandard operating procedures (SOPs)and other quality documentation.Manage and track quality processes withinVeeva 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.QualificationsEducation:Bachelor’s degree in life sciences, healthcare, or related discipline (advanced degree preferred).Experience:5+ years ofClinical Quality Assuranceexperience with a strong foundation in GCP.Prior experience supporting clinical study teams in a QA capacity.Hands-on experience withVeeva 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 duringEastern or Mountain Time Zone working hoursto attend study calls and provide timely QA support.Contract OpportunityThis is afull-time contract roleoffering 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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