Quality Control Analyst I, Raw Materials

Job Description

About Allogene:

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) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

Job Description:

The QC Raw Materials (RM) Analyst will be responsible for inspecting and sampling incoming raw materials for proper identification and conformance to approved specifications. This position reports to Sr. Manager of QC Raw Materials and requires the performance of all activities in a GMP environment by accurately following procedures, maintaining accurate and contemporaneous documentation, and reporting any deviation or discrepancy to manager. Responsibilities are internal and external involving sample management and shipment to external laboratories. The analyst is expected to interact with peers and management within QC, QA, and Supply Chain. This role is an onsite 5 days a week position in Newark, California.

Responsibilities include, but are not limited to:

• Contributes to designing the RM inspection/sampling/testing /vendor qualification programs
• Performs inspections and sampling of raw materials against established specifications.
• Follows procedures and documents activities, ensuring completeness and accuracy per cGMP.
• Initiates nonconformance reports for unacceptable materials, and report issues to manager.
• Evaluates procedures and processes for continuous process improvement.
• Maintains safe and healthy work environment by following standards and procedures.
• Participates in generation of controlled documents such as SOPs, specifications, and test methods.
• May perform in house raw material testing.
• May collaborate with external contract testing laboratories on raw material testing and/or investigations
• Supports building master data in SAP and LIMS systems.
• Able to negotiate, influence, and work in a matrix environment.
• Other duties as assigned

Position Requirements & Experience:

• B.S. in Chemistry, Biochemistry/Biology or related areas.
• Minimum 2-4 years of experience in GMP quality control environment and familiar with raw material sampling and inspection
• Experience in raw material compendial testing is a plus.
• Understanding of GMP requirements and QC systems.
• Experience in using LIMS and/or SAP system is preferred.
• Ability to prioritize effectively to deliver results within 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 and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $33.00 to $37.00 per hour. 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, designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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