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QC Operations Specialist I

Employer
Kite Pharma
Location
El Segundo, CA, United States
Start date
Jul 21, 2019

View more

Discipline
Clinical, Clinical Medicine, Manufacturing & Production
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
We are seeking a highly motivated individual to join us as a QC Specialist I in our commercial cell therapy production center located in El Segundo CA. You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. In this role you will be responsible for incoming sample management of QC samples from manufacturing and support laboratory operations.

Responsibilities (include but are not limited to):
  • Perform inventory of lab supplies and materials.
  • Maintain equipment and instruments supporting Quality Control Department
  • Perform laboratory and computer system audits.
  • Resolve data discrepancies and missing information issues
  • Work with internal and external resources to maintain lab in an optimal state.
  • Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to laboratory operations. Provide updates at daily and weekly meetings.
  • Develop, revise and review SOPs, work instructions and reports.
  • 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.
  • Gather metric information for use in continuous improvement of areas of responsibility.
  • Manage stability data
  • Assist Sample Management with the following:
  • Perform receipt of QC samples, including processing and distribution to QC labs and off-site shipment to internal and external labs.
  • Manage QC retains and disposal of samples.
  • Maintain and operate equipment and instruments supporting sample management.
  • Participate in ad-hoc projects or other duties as needed.
  • Some overtime and weekend work as needed is required
  • Shift is a 4/10 work schedule.

Qualifications
  • Bachelor's degree in Biology or related discipline
  • A minimum of 2 years' experience working in sample management or a regulated business environment.
  • The ideal candidate is proficient with sample chain of custody, general lab procedures such as operating centrifuges, working within a Biological Safety Cabinet and experience in inventory management systems such as FreezerWorks and LIMS
  • The incumbent will need to have the ability to work in a laboratory setting and lift up to 25 lbs.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) related to sample management/retention requirements
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations
  • Proficient in MS Word, Excel, Power Point and other applications
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

IND123

#LI-ZN1

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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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contactcareers@gilead.comfor assistance.

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