About Capsida Biotherapeutics Therapeutics We are a fully integrated AAV engineering and gene therapy company poised to create the next generation of innovative genetic therapies, with life-changing potential for patients with grievous unmet medical needs.
We leverage our proprietary high-throughput AAV engineering platform to create viral vectors with cell-type and tissue level specificity, overcoming many of the biological limitations of early gene therapy efforts.
Combined with our in-house preclinical and manufacturing expertise, we are positioned to create the next generation of AAV delivered gene therapies, dramatically changing the lives of patients.
We are founded on the idea that diverse backgrounds and skill sets combine to create an environment that stimulates innovation and creativity, enabling us to grow into a leader in the AAV gene therapy space.
Our leadership team is comprised of the scientific founders that developed the underlying intellectual property, and experienced industry veterans with a track record for bringing transformative drugs to market.
Together with our partners, we will combine next generation engineered capsids with cutting edge gene editing and delivery modalities to bring novel medicines to patients that need them.
Our research and development labs, offices, and manufacturing space are located in Thousand Oaks, CA.
The Role Reporting to the Senior Manager, Quality Assurance (QA) the Associate/Senior Associate, Quality Assurance will be primarily responsible for the creation, implementation, and assessment of quality systems, procedures, and records to support compliant GMP operations.
Responsibilities include ensuring adherence to agency regulations (GxP) and guidance (ICHQ), industry best practices, local regulations, and internal policies and procedures.
This position works closely with Supply Chain, Manufacturing, Facilities, Document/Data Management, and other GxP supporting functions to ensure compliance.
This position will be based in Thousand Oaks, CA.
Responsibilities
· Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOP’s, material specifications, validation protocols, and reports
· Perform review and approval of clinical production batch records
· Author, review, and approve Quality System records including Deviation, CAPA, and Change Control records including associated root cause and impact assessments
· Define, track, trend, and report quality metrics to management
· Inspect and release GMP raw materials and components against approved specifications
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