Analyst, QC Raw Materials
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 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.
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.
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.
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.