Document Control Manager
Quality Assurance | Santa Monica, CA | Full Time
Kite Pharma Inc, founded in 2009, is dedicated to the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to fight tumor cells. We are a small, dynamic and accomplished team with an exciting growth trajectory for the coming year.
The Document Control Manager (DCM) will manage the development and build out of a company-wide document management system, manage said system and provide management guidance for system execution. The DCM will prepare, approve, and archive paper and electronic documents in a GxP and pharmaceutical research and development setting. This position will report to the Director of Quality Assurance.
Responsibilities (include but limited to):
Prepare document templates including spreadsheets, tables and process flow diagrams:
- Standard Operating Procedure (SOP), Specification, Technical: Development, Qualification, and other document templates as required
- IND and Amendments, Commitments, and Annual Reports
- Spreadsheets, tables and small databases using MS Excel, MS Access, and other tools as required
- Process flow diagrams using MS Word, Power Point and Visio software applications
Develop and maintain document management system, including:
- Develop and implement system for document/data control of regulated/non-regulated information across Kite
- Document management for archival and retention of paper and electronic records
- Manage document access, hierarchy and access control.
- Issue and control laboratory notebooks and other controlled GxP documents.
Document and data management:
- Maintain change control of designated document types
- Maintain accurate document numbering system along with any meta data necessary for good document management
Work directly with document management system vendors to develop, implement and maintain a qualified document system for Kite Pharma
- Train all Kite employees and contract users in our document management system
- Troubleshoot and work directly with IS consultants and software vendors to resolve problems
- Test systems to assure version upgrades and patches are completed
Perform other duties and projects as assigned
- At least 8 years in a document management intensive field
- Bachelors degree in technical discipline (Chemistry/Microbiology/Engineering or similar)
- Microsoft platform expertise, experience with database applications and strong word processing skills
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Experience in the medical, biotechnology and/or pharmaceutical industry
- SQL, database and database application certifications a plus
- Demonstrated knowledge in technical document creation, electronic and paper archival and retrieval
- Proficient in MS Word, Excel, Power Point and other applications with accurate typing skils (>45 WPM)
- Proficient in the use of electronic filing and paper filing systems
- Ability to function with minimal direct supervision
- Willingness to do whatever needs to be done, regardless of level or type of work
- Comfortable in a fast-paced small company environment that requires adjusting workloads based upon changing priorities
- Excellent verbal and written communication skills are essential in this collaborative work environment
Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Boulevard and right off the 10 Freeway. We are able to offer the upside of working in a small, but growing company where everyone knows your name and respects your opinion while at the same time offering top-notch benefits. Did we forget to mention the stock options? To learn more about us, please visit our website at www.kitepharma.com.
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.
No phone calls please and no agencies or recruiters.