Specialist, Facilities Compliance
Facilities | El Segundo, CA | Full Time
Specialist, Facilities Compliance
Kite Pharma is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team. Kite is publicly traded (NASDAQ: KITE) with a current market well over $2 Billion.
We are seeking a highly motivated individual to join us as a Specialist, Facilities Compliance. You will work with the Facilities team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Sr. Manager, Facilities & Engineering.
Responsibilities (include but are not limited to):
- Manage and track deviations within the Facilities department.
- Coordinate efforts across multiple departments to gather supporting justification data to determine appropriate corrective and preventative actions.
- Initiate change control as related to investigations, procedural changes, and other system/equipment upgrades.
- Support internal/external inspections by completing responses and tracking commitments.
- Create SOPs for maintenance and calibration processes.
- Create the Month-End report analysis for completed work orders, out of tolerance conditions and missing instruments resulting in deviations.
- Provide management with deviation completion data and trend analysis.
- Provide backup to Facilities Coordinator and support planning and scheduling work orders in Blue Mountain Regulatory Asset Manager (RAM).
- Collaborate with corporate training department to create department training program.
- May perform other duties as assigned.
- BS degree required with 8+ years of experience in GMP environment.
- Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics, pharmaceuticals and medical devices.
- Experience in a cGMP environment within a Facilities capacity.
- Knowledge of Computerized Maintenance Management System (CMMS), preferably Blue Mountain.
- Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisions.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- Ability to think critically, and demonstrate troubleshooting and problem solving skills.
- Exceptional organizational skills and ability to plan and implement resolutions to technical problems.
- Ability to function efficiently and independently in a changing environment
- Strong computer skills and fluent with Microsoft office applications
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.