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Quality Assurance Manager

POSITION:  Quality Assurance Manager

Company Name: Invitrx Therapeutics, Inc.
Location: Lake Forest, CA
Job Type: Full-time Exempt
Contact Name: Jose Villalvazo
Phone: (949) 856-3142
Salary:  DOE

Job Description:

As a member of the Invitrx Therapeutics team, you will have the opportunity to ensure that all aspects
of the operational business for the US commercial pipelines comply with cGMP. You will be responsible
for providing Quality oversight and approval of deviation, CAPA, and change control records for cell
therapy products, ensuring records are properly initiated, investigated and resolved in accordance with
established timelines. You will lead production record review, lot disposition and provide GMP guidance
to Manufacturing, QC, Engineering/Facilities. Furthermore, you will be responsible for developing and
maintaining processes and procedures to ensure appropriate quality oversight while demonstrating
compliance with cGMP. The unique duties of this position will consist of coordinating release for final
cell-based therapeutic products for clinical applications. Overall, your leadership ability and deep
knowledge of quality will champion the continued development of Invitrx Therapeutics products and
growing success.

Job Requirements:

M.S. degree in a scientific or related discipline and a minimum of 5 years’ progressive
experience in Quality Assurance in a cGMP environment; or equivalent combination of
education and experience.
○ Preferably a PhD
● Must have experience in cleanroom environment requirements, cell therapy, and FDA
● Strong knowledge of US pharmaceutical GMPs
● Demonstrated experience with creating and implementing effective cGMP quality systems,
inclusive of writing SOPs; product release activities, inclusive of batch record and QC record
review; facilitating and closing investigations, deviations and associated CAPA