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QA Specialist - II

Company: ARTECH
Location: Santa Monica
Posted on: January 15, 2022

Job Description:

Job DescriptionEveryone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. We are seeking a Quality Assurance Specialist II at our site in Santa Monica, CA. In this role, you will support supplier qualification and supplier monitoring activities across Kite's global network, with a focus on new products, technologies, and manufacturing sites. You will also support cross functional teams for supplier selection due diligence activities and quality system processes. Knowledge: --- Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs). --- Demonstrates working knowledge of quality assurance systems, methods and procedures. --- Demonstrates knowledge of FDA / EMEA standards and quality systems. --- Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations. --- Demonstrates audit and investigation skills, and report writing skills. Demonstrates good verbal, written, and interpersonal communication skills. --- Demonstrates proficiency in Microsoft Office applications. --- Quality Compliance GMP auditing experience is required. External supplier auditing experience and/or auditor certification (such as ASQ Certified Quality Auditor) is *required*. --- Supplier quality management experience in a GMP environment is *required*. Basic Qualifications: --- Master's Degree and 2 years' experience in GMP environment related field OR --- Bachelor's Degree and 4 years' experience in GMP environment related field OR --- AA Degree and 5 years' experience in GMP environment related field OR --- High School Degree and 6 years' experience in GMP environment related field Preferred Qualifications: --- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. --- Evaluates supplier qualification requests from cross-functional partners and initiates supplier qualification and supplier scope expansion activities. --- Supports qualification of suppliers using risk-based approach through questionnaires and audits. --- Participates in writing or suggesting changes to controlled documents (e.g., SOPs, specifications, forms, etc.) as needed to ensure defined quality objectives are met. --- Execute and maintain quality agreements for suppliers. --- Assesses suppliers for additional qualification activities due to commodity scope change. --- Supports Supplier Quality Performance Monitoring/surveillance activities. --- Participates in Supplier Corrective Action Request (SCAR) process. --- Facilitates supplier notifications (supplier initiated changes) and perform impact assessments from supplier changes. --- Discontinues or disqualifies GxP suppliers based on quality and business needs. --- Support the selection of GxP suppliers with Sourcing through due diligence activities and product quality team assessments. --- Provides quality approvers for change controls related to SICs. --- Participates in health authority (FDA/EMA, TGA) inspections. --- Manages supplier qualifications for new product and new technology projects and new manufacturing site start-ups, including planning, tracking and status updates. --- Represents supplier quality on cross-functional teams for new products, technologies, and sites.

Keywords: ARTECH, Santa Monica , QA Specialist - II, Other , Santa Monica, California

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