Quality Control Analyst I, Raw Materials

Allogene Therapeutics•Newark, NJ

2d•$33 - $37•Onsite

About The Position

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.

Requirements

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
Understanding of GMP requirements and QC systems.
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.

Nice To Haves

Experience in raw material compendial testing is a plus.
Experience in using LIMS and/or SAP system is preferred.

Responsibilities

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