Quality Control Lab Ops Technician II: Wednesday - Saturday 2:30pm-1:00am

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Jul 02, 2019
Ref
R0008764
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a highly motivated individual to join us as a Quality Control Lab Ops Technician II. This position provides Quality Control testing of clinical and commercial product. This position is also responsible for raw material testing, in-process, final product testing and maintenance of QC instrumentations.

Responsibilities include, but are not limited to:
  • Perform testing of raw materials, intermediates and final products by following analytical methods
  • Maintain, calibrate and operate equipment and instruments used for, but not limited to, cell culturing, Flow Cytometry, ELISA and PCR assays
  • Track and test products according to Stability / study protocols and product specifications.
  • Work with internal and external resources to maintain lab in an optimal state. This includes; but not limited to; maintaining and tracking laboratory supplies, following written and/or verbal instructions on aliquoting reagents, following validated system and/or SOPs to process laboratory supplies
  • Monitor and trend data, 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
  • Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections, if needed.
  • Helped with investigations regarding out of specifications (OOS) results; Help with deviations related to analytical procedures.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies
  • Provide suggestions or help with changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
  • Gather metric information for use in continuous improvement within Quality Control Laboratories
  • Other duties as required
  • Shift: 4 days, 10 hours per day, Wednesday - Saturday 2:30pm-1:00am


Qualifications:
  • Bachelor's and 1+ years of Quality Control experience in the biotechnology or related field
  • Knowledge of GMP, SOPs and quality control processes
  • Identifying, writing, evaluating and closing laboratory (OOS) investigations
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Strong written and verbal communication skills
  • Ability to communicate and work independently with scientific/technical personnel
  • Familiar with analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
  • Experience in the biotech and/or pharmaceutical industry, preferred


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Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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