Specialist - Quality Assurance

The Quality Assurance (QA) Specialist will be responsible for assisting in the oversight of cGMP manufacturing and analytical testing performed by contract sites. This key functional role will operate within a cross-functional GXP QA Team and supports internal QA functions. Participate on project teams, serving as the QA representative and escalate issues to senior QA management when appropriate. Review and assess API, drug and finished product(s) batch records and analytical records commercial products in a timely manner. Review Method Validation reports. Manage, process and participate in deviation investigation teams. Interface with cross functional groups or CMOs to process batch documentation and resolve issues. Facilitate the change control process for changes related to commercial products. Maintain tracking logs for quality systems. Participate in or conduct audits of external vendors. Perform, track and report internal audit information for all areas of GxP compliance. Write SOPs for the creation, development or improvement of processes related to quality systems.

According to JobzMall, the average salary range for a Specialist - Quality Assurance in 12780 El Camino Real, San Diego, CA 92130, USA is $67,569 - $90,358.

Neurocrine Biosciences is a publicly traded biopharmaceutical company founded in 1992. Neurocrine develops treatments for neurological and endocrine-related diseases and disorders. In 2017, the company's drug valbenazine (Ingrezza) was approved in the US to treat adults with tardive dyskinesia (TD). The company is also developing treatments that are in various stages of clinical research for Parkinson's disease, Tourette syndrome, and congenital adrenal hyperplasia and with a partner for endometriosis and uterine fibroids.