- Job Type: Full-Time
- Function: Engineering QA
- Industry: Biotechnology
- Post Date: 11/20/2023
- Website: tenayatherapeutics.com
- Company Address: 171 Oyster Point Blvd, South San Francisco, California 94080, US
- Salary Range: $50,000 - $150,000
About Tenaya Therapeutics
Tenaya Therapeutics is a clinical stage biotechnology company. The Company was founded in 2016 by leading cardiovascular scientists from the David J. Gladstone Institutes and the University of Texas Southwestern Medical Center.Job Description
Tenaya Therapeutics is a publicly held biotechnology company committed to a bold mission: to discover, design, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and University of Texas Southwestern Medical Center (UTSW), we are advancing a deep and diverse pipeline that includes both gene therapies and small molecules.
Tenaya is headquartered in South San Francisco, California, USA, with a team that comprises over 140 employees. Inspired by the majesty of Tenaya Peak in Yosemite National Park, our name represents the tenacity of our team in reaching our ultimate peak – the delivery of new therapies for heart disease to the patients who need them.
For more information, please visit www.TenayaTherapeutics.com and follow us on LinkedIn.
Diversity & Inclusion is a core Value for Tenaya Therapeutics, and we encourage those from under-represented communities to apply.
Perform tasks with manager’s supervision to accomplish goals and projects for the QA Operations, Compliance and Quality Management System (QMS). Specifically
- Incoming material release: Review and release starting material including reviewing internal lab test reports and vendor’s CoA.
- Line Clearance: Perform line clearance of manufacturing rooms.
- Document Control: Maintain document control records room inventory and manage records transfer and collection.
- Review documentation and records: Review Environmental Monitoring (EM) results and manufacturing records as needed.
- Assist with QMS tasks, for example, document management in eQMS, training record management in eLMS.
- Assist with Supplier Quality Management.
- Assist with Internal Audit scheduling.
Requirements
- 2-5 years of experience in Quality Assurance for biotechnology or similar industries
- Experience with QMS and records management
- Experience with EM or starting material release
- Experience with Veeva vaults is desirable
- Ability to work on-site daily