
Quality Systems Specialist III
United States - Maryland - FrederickQualityRegularJob 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. 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):
- Serves as Site Process Owner (SPO) for Quality Systems.
- Establish and maintain a Deviation, CAPA, EV and Change Control Management System compliant with regulatory, quality, and Kite requirements.
- Provides guidance and advice on methods, procedures, standardization and requirements associated with these systems.
- Collaborates with cross-functional departments to ensure timely implementation of quality records.
- Support audits (internal, external) in order to verify that regulatory and quality requirements have been met.
- Support Deviation system and ensure proper investigation and root cause analysis are performed.
- Support CAPA/EV system to ensure proper corrective actions are implemented and effective.
- Support Change Control system to ensure proper change and impact assessments are performed and tasks are implemented.
- Develops, implements and delivers training content for Deviation, CAPA, EV and Change Control processes and procedures.
- Responsible for procedure reviews and facilitating procedure updates for the Deviation, CAPA, EV and Change Control systems.
- Assure that personnel are adequately trained in the principals, policies, and procedures of the Deviation, CAPA, EV and Change Control systems.
- Support tracking and communication of site metrics to management.
- Identify and escalate compliance gaps across quality systems.
- Additional duties as assigned.
- These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
Basic Qualifications:
- 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
Preferred Qualifications:
- 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!
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