What are the responsibilities and job description for the Senior Quality Assurance Analyst position at Vertex Advisory Services?
Job Title: Senior Quality Assurance Analyst – Batch Record Review (Cell and Gene Therapy)
Location: Baltimore, MD
Job Type: Long-Term Contract
Job Description:
We are excited to present an opportunity for a Senior Quality Assurance Analyst to join our team in Baltimore, MD. This long-term contract position focuses on cell and gene therapy, with a key emphasis on batch record review and maintaining compliance with industry standards. If you have a strong background in Quality Assurance and are passionate about cutting-edge therapies, we want to hear from you.
Key Responsibilities:
- Perform comprehensive batch record review and approval to ensure compliance with FDA, GMP, and GxP regulations.
- Ensure all manufacturing processes adhere to regulatory standards for advanced therapeutic products.
- Conduct CAPA (Corrective and Preventive Actions) and root cause analysis for quality-related issues.
- Collaborate with cross-functional teams in manufacturing, QA, and R&D to maintain high-quality processes.
- Assist in identifying and implementing process improvements within the quality system.
Qualifications:
- 5 years of Quality Assurance experience, specifically in cell and gene therapy or related fields.
- Strong working knowledge of GMP, GxP, and FDA regulatory standards.
- Proven experience with batch record review.
- Excellent analytical and communication skills.
- Bachelor's degree in Life Sciences, Biotechnology, or a related field.
Why Join Us:
This role offers the opportunity to work with an innovative team on the forefront of cell and gene therapy, contributing to the development of transformative treatments. You’ll play a vital role in ensuring the quality and compliance of therapeutic products that have the potential to change lives.
If you're interested in this opportunity, please send us your updated resume and indicate a convenient time to connect. We look forward to discussing how your skills and experience can align with this exciting role.
