Vacancy expired!
Hi, Role: Technical WriterLocation: Oceanside, CADuration: Long Term
Job Description- 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
Vacancy expired!