Quality Systems Specialist IIIUnited 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. Join us in our mission!
We are seeking a highly motivated individual to join us as a Quality Systems Specialist III at our new world class manufacturing facility in Frederick, Maryland. The facility is a Center of Excellence for T cell therapies targeting tumor mutations and antigens.
The Specialist will ensure quality product and timely delivery – every patient, every time. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy. Further, this individual will provide oversight of Kite’s quality systems including Deviations, CAPAs, Change Controls, Training, and reporting associated metrics, reporting into the Sr. Manager of Quality Systems.
Responsibilities (included but not limited to):
- Implement, handle, audit and maintain Kite Pharma quality systems.
- Ensure Quality Systems conform to regulations and quality policies.
- Support Quality Systems governance for Deviations, CAPAs, Change Control and Quality Metrics.
- Serve as site Subject Matter Expert (SME) for Deviations, CAPAs and Effectiveness Verification
- Support quality assessments of internal operations to analyze compliance and assess risk.
- Support all facility client audits and regulatory inspections.
- Support, develop and deliver technical and/or compliance training to Kite site staff.
- Coach Site staff on Root Cause Analysis development.
- Review and approve procedures, which include, but are not limited to: SOP's, controlled forms, and work instructions.
- Identify compliance risks and raise the issues to appropriate levels of management for resolution.
- Capture metric information for use in continuous improvement of areas of responsibility and report to management, as needed.
- Master’s Degree and 3+ years’ experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR
- Bachelor’s Degree and 5+ years’ experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR
- High School Degree and 9+ years’ experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
- Working within Quality Systems.
- Knowledge of training processes/systems and regulatory requirements (21 CRF Part 11/210/211).
- Strong knowledge of GMPs.
- Solid understanding of Deviation, CAPA, CC, Auditing practices/strategies.
- Excellent writing and editing skills.
- Works on multiple assignments in collaboration with various department system owners.
- Knowledge with aseptic manufacturing processes.
- Advanced Skills with MS Office applications Word, Excel, Access, PowerPoint, Smartsheet, Tableau as well as Adobe Acrobat.
- Experience in electronic Quality Management Systems, Document Management Systems, and Training Management Systems.
- Ability to communicate and work independently with scientific/technical personnel.
- Excellent interpersonal, verbal and written communication skills are meaningful in this collaborative work environment.
- Proactive, detail-oriented and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Experience with Cell Therapy Manufacturing, if possible.
- Advanced Skills in Smartsheet and Tableau strongly preferred.
Does this sound like you? If so, apply today!