US-CA-Corona: Sr. Quality Engineer
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Sr. Quality Engineer
Lead investigations related to product and process deviations. Daily activities may include auditing, document review, investigations, writing of reports and quality system development and implementation in both an individual and team setting. Review electrical, mechanical and software/computer specifications in manufacturer and blue print form. Assure protocols challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems or equipment, and that protocols are approved through proper channels. Ensure qualification protocols comply per related SOPs and assure that acceptance criterion related to validation and qualification protocols are met. Interact with all involved personnel in the execution of protocols and gathering of test data. Assure that all test data is gathered and recorded in accordance with cGMP requirements. Ensure the analysis of data meets related protocol acceptance criteria. Deviations are reported as required upon failure to meet protocol acceptance criteria. Review Global and Site validation related SOPs to assure they comply with regulations and site requirements.
Bachelor's Degree in Science, Engineering or related field from an accredited college or university, and nine (9) – thirteen (13) years related experience preferably in quality assurance or engineering validation experience; or, an equivalent combination of education and/or experience in a pharmaceutical environment.
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