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Quality Assurance Specialist I - $8,000* Sign On

Company: Kite Pharma
Location: San Diego
Posted on: January 15, 2022

Job Description:

Job DescriptionWe are seeking a highly motivated individual to join us as a Quality Assurance Specialist I. In this role you will be responsible for executing a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. You will be located at our Oceanside, CA site and report into the Associate Director of Quality Assurance.Key Responsibilities (include but are not limited to):

  • Perform Quality Assurance related production and production related activities
    • Ensure timely assessment and closure of discrepancies, Deviations, CAPAs and Change Controls
    • Ensure timely assessment and closure of Laboratory Investigations
    • Ensure timely assessment and closure of batch and material hold events
    • Communicate lot disposition pending issues to Management
    • Review and disposition raw materials and components for GMP use
    • Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area
    • Perform walk-throughs and process observations
    • Perform Document Control administrative activities including archival and updating of site training records
    • Conduct and support site and global training
    • Support Regulatory Body Inspections of the facility
    • Ensure products are manufactured in compliance with regulatory and GMP guidelines.
    • Escalate issues that may adversely impact timely release of product
    • Identify compliance risks and escalate the issues to appropriate levels of management for resolution
    • Generate and update procedures and forms as needed
    • The standard work week for this position is M-F, however weekend work will be required during manufacturing campaigns to support process operations
    • Perform additional duties as neededBasic Qualifications:
      • Master's Degree and OR
      • Bachelor's Degree and 2+ years' experience in the biological sciences or related field OR
      • AA Degree and 4+ years' experience in the biological sciences or related field OR
      • High School Degree and 5+ years' experience in the biological sciences or related fieldPreferred Qualifications:
        • Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
        • Ability to effectively negotiate and build collaboration amongst individuals
        • Proficient in MS Word, Excel, Power Point and other applications. Experience with Veeva and Smartsheet highly desirable
        • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
        • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing prioritiesDoes this sound like you? If so, apply today!
          • This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.#QCQA123

Keywords: Kite Pharma, San Diego , Quality Assurance Specialist I - $8,000* Sign On, Other , San Diego, California

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