Product Owner

Description:

Lab Ops Specialist I

Location: On-site @Santa Monica at RDMC Location.
Hours/Days: (Tuesday-Sat) Flexible hours.

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.

We are seeking a highly motivated individual to join us as a Lab Ops Specialist I in Quality Control Sample Management in Santa Monica, CA.

Responsibilities
•Perform QC sample receipt, processing and distribution for testing and storage
•Perform Apheresis Accession, Inspection, and assist QA with product returns
•Maintain, operate equipment and instruments supporting sample processing
•Work with internal resources to maintain lab in an optimal state
•Perform Cryo sample disposition and shipment
•Track inventory of lab supplies and materials
•Track inventory of retain samples, stability samples, test materials
•Track and distribute samples according to Stability protocols
•Troubleshoot standard issues and identify when a deviation from standard process occurs
•Gather metric information for use in continuous improvement of areas of responsibility
•Data entry and review
•Support generation of CoAs for product release
•Revise and review SOPs, work-instructions, forms, sampling plans
•Monitor the GMP systems currently in place to ensure compliance with documented policies
•Assist with audits, walkthroughs, inspections, when necessary
•Additional duties as assigned

Basic Qualifications
•Bachelor's Degree OR
•AA Degree and 1+ years of experience in Quality Control/GMP Environment OR
•High School Degree and 3+ years' experience in Quality Control/GMP Environment
•Physical requirements: Ability to lift up to 30 lbs

Preferred Qualifications
•Degree in biotechnology or related field with Quality Control experience
•Working knowledge of GMP, SOPs and quality control processes
•Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
•Proficient in MS Word, Excel, Power Point and other applications
•Ability to communicate and work independently with scientific/technical personnel
•Strong written and verbal communication skills
•Comfortable in a fast-paced small company environment with direction and able to adjust workload based upon changing priorities
•Experience with LIMS
•Ability to work with a variable schedule