Quality System Specialist II

Company: GForce Life Sciences
Location: Oceanside
Posted on: August 2, 2022

Job Description:

Our Client is seeking a highly motivated person for the role of QA Specialist II- Quality Management Systems. This individual will be responsible for a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements and will be located at our Oceanside, CA site and report to Senior Manager of Quality Assurance. This is a Contract To Hire role.Duties / Expectations of Role

• Support activities related to Quality Management System (QMS).
• Performing tasks and troubleshooting of all activities in electronic systems for Quality Management Systems (Agile, Veeva, LMS and equivalent)
• Product Complaints and Returns - support investigations in cooperation with Senior Manager of QA, Regulatory Affairs, and other departments
• Deviations, Investigations, Root Cause Analysis, Laboratory Investigations and Out-of-Specifications for the site - ensure timely initiation by the representative department; evaluation, review, and QA approval of investigations to ensure completion is appropriate to the level/ classification of discrepancy
• Change Controls - support initiation, evaluation, and completion to ensure timely and satisfactory implementation of changes by all departments at the site
• CAPA program - support and monitor all CAPAs to ensure implementation is completed according to the established Kite Pharma procedures and policies
• Support and back up for Document Control and Learning Management Systems for the site.
• Provide information for Product Quality Reviews and participate in review of PQRs
• Provide information for metrics related to QMS and Compliance in support of the Management Review
• Support activities for Gap Analysis for Quality Management Systems as requested by the manager
• Support Internal Audit and Corporate Audit systems as requested by the manager.
• Collaborates with cross-functional departments to ensure timely implementation of quality systemsMandatory Requirements
  • 3+ years of experience with BS degree in the biological sciences or related field
  • Working knowledge of electronic Quality Management Systems
  • 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. Familiarity with electronic systems for Batch Record, Quality Management Systems, Veeva and SmartsheetTerm & Start
    • 6 Months Contract with the opportunity to convert to FTE after 6 months.
    • Full time (40 hours/week)
    • On-Site in Oceanside, CA
    • W2 Benefits included (Medical, Dental, and Vision)
    • Vaccine is required

Keywords: GForce Life Sciences, Oceanside , Quality System Specialist II, Other , Oceanside, California