Quality Control Specialist I - $8,000* Sign On美国 - 加利福尼亚州 - 埃尔塞贡多质量正式员工
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.
Kite is seeking a highly motivated individual to join us as a QC Specialist in our new commercial cell
therapy production center located in El Segundo CA. In this role you will report into the Associate Director Quality Control Microbiology and be responsible for technical oversight of Microbiological methods and programs for cell therapy products. You will also be responsible for providing Quality Control support of commercial manufacturing of final drug product.
Responsibilities include (but are not limited to):
- Conduct investigations regarding environmental monitoring (EM) action level excursions, and out of specifications (OOS) results.
- Investigate and manage deviations related to microbiology procedures and cleanroom related activities. Determine corrective/preventative actions (CAPA) and drive implementation.
- Assist in the generation of trend reports on environmental monitoring and product release data. Frequently update management on trends. Implement corrective action plans when necessary.
- Assist in the transfer and provide technical oversight and training of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability).
- Assist in the management of laboratory activities and provide technical direction to staff.
- Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release.
- Develop, revise and review SOPs, qualification/validation protocols and reports.
- Support execution of protocol or study as needed.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. Assist in the gathering of metric information for use in continuous improvement of areas of responsibility.
- Support the QC Microbiology and Aseptic Techniques Training programs.
- Additional duties as assigned.
- These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
- Master’s Degree and OR
- Bachelor’s Degree and 2+ years’ experience in a biotech/biopharmaceutical setting OR
- AA Degree and 4+ years’ experience in biotech/biopharmaceutical setting OR
- High School Degree and 5+ years’ experience in biotech/biopharmaceutical setting
- Experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required.
- Familiar in various microbiological techniques including rapid release methods, and environmental monitoring processes with reference to cell therapy product.
- Familiar in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes is preferred.
- Familiar with Environmental Monitoring requirements and tests (viable and non-viable),Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals
- Ability to gown for entry into Aseptic core and supporting areas.
- Working knowledge of quality systems and regulatory requirements (21 CRF Part
- Strong knowledge of GMP, SOPs and quality control processes
- Strong data integrity knowledge and practices.
- Identifying, writing evaluating and closing OOS’s and investigations.
- Strong knowledge of aseptic manufacturing and EM processes
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Strong understanding and experience operating within an GMP environment
- Exceptional attention to detail and ability to keep track of multiple ongoing projects
- Excellent oral and written communication skills
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to perform duties with minimal supervision and must be adaptable to a dynamic and fast-paced environment
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Does this sound like you? If so, apply today!
* This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.