Quality Control Specialist III

1 day ago

Oceanside, California, United States Gilead Sciences Full time
Job Title: Quality Control Specialist III - Microbiology

We are seeking a highly motivated and experienced Quality Control Specialist III - Microbiology to join our team at Gilead Sciences. As a key member of our Quality Control team, you will be responsible for leading the development and refinement of methodologies for microbiological testing, developing and implementing qualification/validation protocols and reports, and project leading (or supporting) in Tech Transfer and validation of microbiological methods and automation in QC.

Responsibilities:
  • Lead the development and refinement of methodologies for microbiological testing
  • Develop and implement qualification/validation protocols and reports
  • Project lead (or support) in Tech Transfer and validation of microbiological methods and automation in QC
  • Lead the implementation of Method Suitability Testing (MST) protocols for Microbiology assays
  • Lead, develop, and implement multiple simultaneous projects that are complex and technically demanding through significant interactions with internal staff and external experts
  • Draft laboratory investigations, deviations, CAPAs, and support troubleshooting associated with QC Microbiology responsibilities identified through GMP manufacturing and QC support processes
  • Monitor the GMP systems currently in place to ensure compliance with documented policies
  • Lead teams to support deviations, investigations, CAPAs, and Laboratory Investigations/OOS
  • Manage global change controls and annual report data from QC Microbiology
  • Assist in establishing user requirements for purchase and qualification of Kite's QC microbiology equipment and materials/reagents
  • Implement protocols for the qualification and re-qualification of new and current instrumentation, and review qualification/validation protocols and reports
  • Work with internal and external resources to maintain equipment in an optimal state
  • Develop, revise, and review SOPs, test methods, and work instructions
  • Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies
  • Support and participate in regulatory agency inspections
  • Identify and lead teams for lean improvement activities
Requirements:
  • Master's and 3+ years of Pharma experience OR
  • Bachelor's and 5+ years of Pharma experience OR
  • Associate and 7+ years of Pharma experience OR
  • High School Diploma/GED and 9+ years of Pharma experience
Preferred Qualifications:
  • Experienced in cell and gene therapy
  • 10 years of experience in Quality Control Microbiology
  • Excellent background in microbiological testing and sound knowledge of sterility, bioburden, and endotoxin testing's scientific principles
  • Excellent working knowledge of GMP
  • Experience in validating various QC Microbiology methods
  • Comfortable in a small company environment with minimal direction and able to adjust workload based upon changing priorities

We offer a competitive salary range of $104,805.00 - $135,630.00, as well as a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.*

For additional benefits information, visit: Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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 .

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 contact for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' 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.

Change The World With Us

Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.

We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.

While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

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