QA Specialist

Company: HAYS
Location: Santa Monica
Posted on: January 16, 2022

Job Description:

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.A Biotechnology Company is seeking a QA Specialist in Santa Monica, CA.Role DescriptionWe 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.--- 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*.Skills & Requirements--- 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--- 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.Why Hays?You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it. Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.--- Medical --- Dental --- Vision --- 401K --- Life Insurance ($20,000 benefit)Nervous about an upcoming interview? Unsure how to write a new resume?Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting. Hays is an Equal Opportunity Employer.Drug testing may be required; please contact a recruiter for more information. #1130130

Keywords: HAYS, Santa Monica , QA Specialist, Other , Santa Monica, California