Quality Control Specialist I - Technical Services

Arbeitsbeschreibung

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, a Gilead Company, is seeking a highly motivated individual to join us as a QC Specialist I in the QC Technical Services group within RDMC Clinical Quality Control in Santa Monica.

Responsibilities:

• Collaborates with cross functional team members to ensure & complete the Quality records (CAPA/Deviation) or Project/validation/qualification reports and other key deliverables in due time.
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
• Prepares content for quality meeting, conferences, presentations including assembling and organizing data into text and figures.
• Reviews or creates process trending charts for QC processes.
• Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures.
• Stay aware of trends and new tools and technologies in the technical writing industry.
• Supports basic lab operations as assigned.
• Full working knowledge of GMPs, GLPs, pharmacopeial, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.

Basic Qualifications:

• Master’s OR
• Bachelor’s and 2+ years of relative experience OR
• Associate and 4+ years of relative experience OR
• High School Diploma/GED and 5+ years of relative experience

Preferred Qualifications:

• Bachelors (with 5-year GMP experience) or Master’s (with 3-year GMP experience)
• Background in immunology & Microbiology is a big plus
• Excellent writing skills; able to produce clear, compelling, and eloquent text.

• Outstanding organizational skills.
• Excellent communication, editing and proofreading skills.
• Must be flexible and able to drive deadline-driven projects to completion.
• Must be able to work independently and as part of a team.
• Must be able to coordinate work with numerous collaborators and manage complex processes.
• Must be advanced user of Microsoft Office, GMP Quality Systems such as:, LIMS, TrackWise
• Hands on experience in routine analytical and Microbiological laboratory procedures (including ddPCR, qPCR, Flow cytometry, ELISA, Endoscan, BacT etc.,)

Does this sound like you? If so, apply today!