
Quality Assurance Lead
2 weeks ago
We are seeking a skilled Quality Assurance Specialist to join our team. In this role, you will play a key role in guiding study teams and ensuring quality oversight for ongoing clinical trials.
The successful candidate will be responsible for providing QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, and study operations and trial oversight meetings.
- Primary Responsibilities:
- Ensure compliance with Good Clinical Practice (GCP) and internal quality standards.
- Provide QA support for clinical study teams, addressing QA-related questions and providing clear and actionable guidance.
- 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.
To be successful in this role, you will need to possess the following skills and 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.
- 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.
As a member of our team, you can expect:
- Opportunities for professional growth and development.
- A dynamic and supportive work environment.
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