Quality Assurance Specialist- Manufacturing GMP Industry

Company: Volt
Location: Torrance
Posted on: March 26, 2020

Job Description:

A great Pharmaceutical company in Torrance CA is hiring for a Quality Assurance Specialist role. This is a Day shift and you must--have a Chemistry, Biochemistry or Life Science Degree. Essential Job Responsibilities:--- Participate and contribute in supplier audits, annual product review, change control, CAPA, complaint handling, document control systems, and cGMP training of employees. Back up activities of Quality Assurance Specialist (Operations) which includes working on deviations, batch record review, clinical and commercial product release. Enter data into databases in accurate and timely manner.--- Insure that Quality System, cGMP and ICH guidelines are followed on site. Help with annual analysis of upgrades to Quality System in terms of both Operations efficiency as well as new FDA or ICH regulatory changes.--- Partner with Regulatory Affairs, Manufacturing, Development, Marketing as well as Corporate Quality on customer projects, regulatory submissions, and harmonization of PPL Group's Global Quality standards across PPL Group sites.--- Maintain our successful record of accomplishment with FDA and other regulatory agencies.Required Skills/Qualifications:--- Minimum undergraduate degree in Chemistry, Biochemistry or other life science degree.--- Minimum of four to six years of experience in quality assurance, and compliance in the cGMP active pharmaceutical ingredient contract manufacturing industry or pharmaceutical company that internally produces their APIs.--- Experience in FDA, EMEA inspections with documented successful outcomes.--- Demonstrated ability to apply comprehensive, in-depth understanding of pharmaceutical industry regulatory compliance with emphasis on cGMP, IND, and NDAs.--- Excellent technical writing skills and effective communication skills needed--- Experience in all aspects of Quality Assurance from pre-clinical to commercial product phases (phase appropriate cGMPs)Please send your resume to icarroll@volt.com or call Ida at 805-979-3345 Volt is an Equal Opportunity Employer

Keywords: Volt, Torrance , Quality Assurance Specialist- Manufacturing GMP Industry, Other , Torrance, California