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Quality Assurance, Sr Specialist (Manager level)

United States - Maryland - FrederickQualityRegular

Job Description

Everyone 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 looking for a Sr Quality Assurance Specialist to join our Quality team at our new state-of-the-art Frederick, MD facility.

*** Shift is 4x10's - Sunday-Wed or Wed-Saturday - day/1st shift ***

Responsibilities:

  • Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.
  • Coordinate and facilitate Quality Assurance related production and production related activities, including:
  • Approval of electronic batch records and manufacturing labels.
  • Assessment and closure of discrepancies, deviations and change controls requests.
  • Assessment and closure of laboratory investigations.
  • Timely assessment and closure of batch and material hold events.
  • Communicate lot disposition pending issues to management.
  • Review of batch manufacturing and testing documentation for timely delivery of final product.
  • Ensure that tests are performed, and products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines.
  • Support development of SOPs and review/approve SOPs to ensure quality objectives are met
  • Review and approve test methods, manufacturing/quality control qualification/validation protocols and reports.
  • Review and approve manufacturing production records.
  • Compile and verify all batch related documents into a final product lot disposition package.
  • Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPA.
  • Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
  • Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities.
  • Provide periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPA.
  • Review and disposition raw materials, components, and labels for GMP use.
  • Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies.
  • Facilitate disposition, team meetings and provide process training to staff.
  • Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
  • Manage and participate in internal, external and regulatory inspections and audits at the site.
  • May serve as a team representative on cross-functional projects to support more senior colleagues in the function.
  • Act as a mentor of junior staff.
  • Perform other duties as required.

Basic Qualifications:

  • Master’s Degree and 4+ years’ experience in GMP environment OR
  • Bachelor’s Degree and 6+ years’ experience in GMP environment   OR
  • High School Degree and 11+ years’ experience in GMP environment   

Preferred Qualifications:

  • Proficient in GMPs
  • Proficient in application of QA principles, concepts, industry practices, and standards. 
  • Has proven analytical and conceptual skills.
  • Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
  • Demonstrates excellent verbal communication, technical writing and interpersonal skills.
  • Demonstrates working knowledge and good proficiency in Microsoft Office applications.
  • Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
  • Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control
  • Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.

Does this sound like you?  If so, apply today!