Senior Specialist, Quality Assurance
Quality | Newark, CA | Full Time
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 world-class 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.
Allogene is seeking a highly motivated individual contributor for the role of Senior Specialist of Quality Assurance to support the start- up of facility and equipment, development of GMP disposition processes for materials and products manufactured at Newark Facility. The position will support manufacturing operations including review of executed batch records, investigations, change controls and other associated quality documentation as well as oversight of operations on the manufacturing floor. Must be able to work independently and professionally in the execution of production. Must be able to manage responsibilities in a fast‑paced environment, meeting production objectives, while ensuring quality requirements are met. This position may start at South San Francisco and move to Newark, CA when facility is ready for staff.
Responsibilities include, but are not limited to:
- Provide QA support for on the floor manufacturing operations
- Review production batch record for compliance to Good Documentation Practices and established SOPs/standards
- Propose and implement a process for managing the raw material and product disposition process
- Review and approve Certificate of Analysis and Certificate of Conformance for batch release
- Perform documentation review of media fills and media fill protocol approvals as needed
- Create / revise documents (SOPs/Forms/templates) as needed
- Support QMS processes including deviations, CAPAS and change controls
- Manage project teams as assigned by the supervisor
- Assist with training other individuals within the department
- Review specifications/ standards/ inspection plans for compliance to current regulatory requirements.
- Participate in audits as assigned by management
- Other duties as assigned by supervisor
Requirements & Experience:
- Bachelor’s degree in related science or engineering field with at least 5 years of experience in GMP regulated biopharmaceutical manufacturing with preference for experience with gene and cell therapy products
- Knowledge of quality systems and regulatory requirements including relevant US and EU guidelines
- Direct experience with batch review and release of viral vector and or cell therapy product lots preferred
- Knowledge about qualifications and validation of facility/utility and computer systems is preferred
- Knowledge of quality control principles and practices is preferred
- Advanced computer skills with MS Office applications Word, Excel, PowerPoint, as well as Adobe Acrobat
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Ability to work independently and as part of a team
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Candidates must be authorized to work in the U.S.
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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.