QC Lead Engineer

1 week ago


Phoenix, Arizona, United States Mayo Clinic Full time

The Quality Control Lead Engineer is responsible for performing, analyzing and investigating quality control assays, including in-process, release and stability tests, developing and performing & analyzing environmental monitoring, identifying trends and leading assay development and validation tasks as directed by supervisor, providing qualification and validation support for manufacturing processes that are essential to the clinical production.

Perform all GMP related activities strictly according to SOPs with accurate and complete documentation associated with the testing, in compliance with cGMP, principles of Data Integrity and good documentation practices. Leads self and others in investigations and process improvements including CAPAs and Change Controls. Ensures compliance with all applicable Federal and State accrediting agency requirements in the testing of biopharmaceutical products manufactured in the current Good Manufacturing Practices (cGMP) facility. Lead in identifying, adapting, optimizing and validating new analytical procedures for testing as necessary and is a subject matter expert (SME) multiple areas of QC operations. Responsible for developing, reviewing and revising Standard Operating Procedures as necessary. Performs general laboratory activities as assigned by supervisor. Complete and maintain updated all training required to perform assigned tasks and develops and implements training programs. Leads audits of processes and data and a point of contact for external audits


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