Quality Analyst, Quality Assurance
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Job Description
Quality Analyst supporting Quality Assurance across clinical-stage cell therapy programs at BrainChild Bio. Ensuring compliance with the highest standards of quality, safety, and reliability.
Responsibilities:
- Support Quality review of batch records, test results, and associated documentation to enable timely lot disposition.
- Assist in tracking manufacturing, testing, and release activities for clinical batches to support timely and compliant product delivery to patients.
- Coordinate with internal teams (Quality, Patient Operations, Program Management) and external partners, including CDMOs, to track batch status and communicate timelines and issues.
- Support Quality oversight activities to ensure compliance with applicable GMP regulations across internal operations and external partners.
- Assist with deviation, investigation, and CAPA tracking and follow-up.
- Contribute to tracking and reporting of key Quality and operational metrics.
- Assist in preparation of materials for Quality Management Reviews and internal reporting.
- Participate in inspection readiness activities and support audit preparation efforts.
- Provide general Quality support to ongoing manufacturing and development activities as needed.
- Provide support to ensure compliance of the Quality Management System and associated documentation.
- Support Internal Audit processes
- Travel required: 20%-40%
Requirements:
- Bachelor’s degree in life sciences or related field.
- 1–3 years of experience in a Quality or GMP-regulated environment (biotech, pharma, or cell/gene therapy preferred).
- Familiarity with GMP principles and documentation practices.
- Strong attention to detail, organizational skills, and ability to manage multiple priorities.
- Effective communication skills and ability to work cross-functionally.
- Experience supporting manufacturing or working with external partners (e.g., CDMOs) is a plus.
- Ability to thrive in a fast-paced, mission-driven, small company environment and adapt to shifting priorities.
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