Quality Assurance Specialist III

Job Location: Oceanside, CA Qualifications: Bachelor’s degree in Science or equivalent work experience. 5-10 years working in a GXP or ISO regulated environment. 2-5 years in a Quality Assurance related role Must have excellent skills in organization, negotiation, problem solving and time-management. Able to attend to detail and act decisively. Must have excellent interpersonal, written, oral presentation and verbal communication skills. Proficient in Microsoft Word, PowerPoint, Access and Excel. Must be able to travel domestically/internationally (~10%) Duties & Responsibilities: Managing, coordinating, facilitating and implementing quality assurance standards based on applicable FDA, ICH and ISO requirements. Reports to the Quality Manager: assists management with the development and implementation of internal controls, standards, processes and procedures for managing the company’s QMS and quality programs. Directs quality assurance methods, participates with internal Quality training for all the company employees Monitors production conformance with QA standards and procedures Participate in the initiation, documentation, and management of quality events (e.g. deviations, CAPA, change control, complaints, product returns/recalls). Conduct employee training on applicable Quality SOPs, regulatory requirements and ISO/ICH standards Iinitial contact and quality control resource for quality event or nonconformance identification, report write-up and quality event documentation/investigation. Proposes appropriate correction, corrective action plans and measures and effectiveness verification for CAPA/Deviation resolution and closure. Review/release regulatory document packages (including batch records, CoAs and other related documents) for each product Generates/signs/approves applicable records including Certificate of Conformance and/or Certificate of Analysis for product lot/batch releases. Perform internal and participate in external customer or notified body quality audits. Conduct supplier assessments and routine/qualification audits in accordance to Supplier Management program. Maintain ASL as required. Prepare audit plans, agenda and final reports based on audit findings as appropriate, Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action plan is implemented. Job Type: Full-time Pay: $30.00 - $40.00 per hour Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Schedule: 8 hour shift Application Question(s): How many years of experience working in a GXP or ISO regulated environment? How many years of experience in a Quality Assurance related role? Are you amenable to work in Oceanside, CA? Do you have working permit? Where is your current location? Work Location: In person