Senor Technical Writer

Hi, Role: Technical WriterLocation: Oceanside, CADuration: Long Term

• Responsible for working with Subject Matter Experts (SMEs) to create, improve and present changes to Kite MVP-01 lifecycle documents (ie. Validation protocols, SOP’s, WRK’s, TM’s)
• Responsible for administering all aspects of the Quality Management System (QMS) as it relates to deviations and Laboratory investigation / LIRs. You will work with SMEs to get all needed data into the QMS to efficiently and punctually open and close Deviations as required by the QC department.
• Investigate, author, and execute corrective actions for deviations as required by the QC department.
• Active participant in seeking to make the Manufacturing department better at all aspects of its operations.
• QMS expert for the QC department.
• Work closely with the cross-functional team to facilitate communication and execute process improvements in a timely fashion.
• Present work during leadership councils and audits as required by QC.

• Bachelor’s degree with 4+ years of experience in quality, engineering, manufacturing, and biotech/pharma OR
• AA degree with 5+ years of experience in quality, engineering, manufacturing, and biotech/pharma OR
• High School degree with 6+ years of experience in quality, engineering, manufacturing, and biotech/pharma

• BS-related field and 4+ years of experience in an FDA-regulated industry.
• A working knowledge of the cGMPs and documentation practices required to maintain compliance to the cGMPs
• Experience with writing Validation protocols, Deviation management Systems and performance of investigations in a GMP/GDP environment
• A working knowledge of the key components of a cGMP QMS like CAPAs, Deviations, Laboratory investigations, life cycle documents and all necessary approvals
• Familiarity with common QMS systems like AGILE etc
• Able to read and interpret technical documents such as Technical Reports, Process Summaries, SOP’s, WRK’s
• Excellent listening skills that will to allow you to gather all information necessary to create clear and concise QMS documentation.
• Excellent writing skills that allow you to clearly communicate all the information you gather across all functions (QA, QC, Manufacturing, Supply Chain, IT).
• Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team-based decisions.
• Ability to think critically with demonstrated troubleshooting and problem-solving skills.
• Ability to function efficiently and independently in a changing environment.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Well-developed computer skills and fluent with Microsoft office applications.
• Some experience with cell culture and preferred if it is with a cell therapy