Specialist, Quality Assurance (Contract)

About Allogene:

Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.

At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

About the role:

Job Description:

Allogene is seeking a highly motivated individual contributor for the role of Specialist of Quality Assurance to support the start- up of facility and equipment, development of GMP disposition processes for materials and products manufactured in Newark, CA. 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.

Responsibilities include, but are not limited to:

• Review production batch record for compliance to Good Documentation Practices and established SOPs/standards
• Initiate raw material and product disposition process
• Assist with QA retain inspections w/ QC and Sample Mgmt.
• 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
• 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.

We offer a chance to work with talented people in a collaborative environment. The expected salary range for this role is $55.00 to $65.00/hr. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene 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. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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