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Quality Assurance Manager in San Diego, CA



$100K - $150K*


Quality Assurance


5 - 7 years

Job Description

The Quality Assurance Manager is responsible for providing compliance and regulatory support to all aspects of the organization. This is performed by working closely with Assay Development, Manufacturing Technical Transfer & Operations and Laboratory Operations. This role will process batch records, labeling & release of product, approve deviations, nonconformance reports, CAPAs, and qualification reports.

The Quality Assurance Manager will lead the supplier program and audit program (internal, external and 3rd party). This person will be organized, self-motivated and have strong oral and written communication skills as they will work closely with internal customers to draft or revise documents and procedures. In addition, this position will support the Quality Document Control function and other Quality personnel needs as required.

This position will work independently and manage the day-to-day activities, priorities and provide guidance to QA Engineers, QA Spec

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Valid through: 2020-4-9

About Epic Sciences

Epic Sciences is a company that is developing highly sensitive diagnostic tests to molecularly characterize the circulating tumor cells (CTC) in the blood. The team at Epic has developed a powerful rare-cell detection and characterization platform, which was founded on unique technology from Dr. Peter Kuhns lab. This technology has been exclusively licensed from The Scripps Research Institute. The technique involves analyzing all the nucleated cells in a blood sample to find CTCs and CTC subtypes and assessing them for genetic mutations and abnormal protein expression. Kuhn is also a co-founder of the company. Epic Sciences began formal operations in 2010. Dr. David Nelson was the first President and CEO as well as Director and co-founder. Other co-founders included Dr. Dena Marrinucci, Steven French, Dr. Xing Yang, and Mike Coward. Dr. Nelson was CEO from 2010 until July 2013. During that time, the Epic team industrialized the academic technology from the Kuhn lab, established numerous academic collaborations (Memorial Sloan Kettering, Moffitt, MD Anderson, Royal Marsden, Yale etc.), received multiple grants from the National Cancer Institute, signed collaborations with over 10 pharmaceutical companies for many clinical studies including over 3000 patients, closed two rounds of private equity financing with top tier investors (Domain Associates, Roche, and Pfizer), executed a partnership with LabCorp to provide global reach, partnered with Microsoft to provide innovative and scalable computational solutions, and initiated a business strategy to pursue both independent diagnostic products as well as companion diagnostics with its pharmaceutical partners.
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* Ladders Estimates