QA Specialist, Supplier Quality (Contract)
Quality | South San Francisco, CA | Contract
About Allogene Therapeutics, Inc:
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
We are seeking a highly motivated individual to join us as a QA Specialist, Supplier Quality for a 6+ month contract opportunity. As a QA Specialist, you will interact with Process Development, Manufacturing, Supply Chain, as well as raw material suppliers and GxP service providers to coordinate activities in support of the Supplier Quality Management Program at Allogene.
Responsibilities (include but are not limited to):
- Work extensively with cross-functional team and external suppliers to track and coordinate completion of supplier qualification activities.
- Support the Audit Management Process by managing agenda setting, audit coordination, and CAPA follow up.
- Ensure supplier files and database are current and accurate.
- Track supplier investigations via the Supplier Correction Action Request process.
- Support execution of the Supplier Change Notification process by ensuring that processing of change notification is timely.
- Other duties as assigned
- Bachelor’s degree in Engineering, Chemistry or biological sciences required.
- Minimum of 5-7 years of working in Supplier Quality Management
- Working knowledge of quality system requirements such as US FDA GMP, EMA, and ICH guidelines
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Advanced skills with MS Office applications Word, Excel, PowerPoint, as well as Adobe Acrobat.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.