Senior Quality Assurance SpecialistUnited States - Maryland - FrederickQualityRegular
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.
This role requires 10hr shift work. Sunday-Wed or Wed-Saturday.
- 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.
- 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
- 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!