Quality Control Specialist I

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 04, 2019
Ref
R0009401
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

Responsibilities (include but not limited to):
  • Operate independently on project teams, performs risk assessments and process optimization
  • Coordinates validation efforts for utilities and equipment such as water, compressed gases, BacT
  • Coordinates validation efforts for assays including Bioburden, Sterility and Endotoxin - acts as the subject matter expert for all Microbiology analytical assays
  • Participates in AOQ and APV strategies -
  • Develops, revises and reviews SOPs, User Requirement Specifications and IND documents
  • Limited Environmental Monitoring Testing in Grade A-D/ISO 5-7 areas
  • Perform microbiological assays per compendial guidance
  • Participate in validation writing testing activities
  • Participate in LIMs validation
  • Data trending and review
  • Review data
  • Coordinate and help develop training curriculums


Requirements:
  • Bachelor's degree in microbiology preferred with a minimum of six years' relevant experience or Master's degree with a minimum of 4 years' experience
  • Strong aseptic background required with relevant pharmaceutical microbiology cleanroom experience
  • Strong QC experience required
  • Must have strong knowledge of compendial methods and regulatory guidance


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.

For jobs in the United States:

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.

For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.