Job Description
Specific Job 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, CAPAs and change controls requests.
- Completion of change actions for change controls.
- Assessment and closure of laboratory investigations.
- Timely assessment and closure of batch and material hold events.
- Communicate lot review pending issues to management.
- Review and disposition of batch manufacturing documentation for timely disposition of final product.
- Ensure 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.
- Review and disposition of raw materials.
- Review and compile 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 CAPAs.
- 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 CAPAs.
- Provide periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPAs.
- Review and disposition raw materials, media/reagents, components, and labels for GMP use.
- Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies.
- 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.
- Participate in continuous improvement projects.
- May serve as a team representative on cross-functional projects to support more senior colleagues in the function.
- Acts as a mentor to junior staff.
- Provide process training to team, as needed.
- These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
Knowledge
- Proficient in GMPs and/or GLPs.
- Proficient in application of QA principles, concepts, industry practices, and standards.
- Demonstrates ability to effectively manage multiple projects/priorities.
- 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.
Basic Qualifications
- 7+ years of relevant experience in a GMP environment related field and a BS/BA.
OR
- 5+ years of relevant experience and a MS.
