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Quality Control Specialist Ii
4 months ago
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
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. Would you like to join us in this mission?
We are seeking a highly motivated individual to join us as a Quality Control professional reporting to the SR. Manager of Quality Control Analytical. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.
**Responsibilities**:
- Support assay execution to assess T cell function and viral vectors such as Flow Cytometry, PCR and Cell based assays.
- Successfully implement and document laboratory procedures and experiments with great attention to detail.
- Contribute to a dynamic, exciting culture that embraces teamwork and passion.
- Become trained on laboratory procedures including PCR platform, Flow and ELISA.
- Support completion of Quality records (CAPA, Deviation, LIR).
- Support investigations regarding out of specifications (OOS) results and address and manage deviations/CAPAs related to analytical procedures.
- Assist in review data and assists with process trending procedural updates and other documentation.
- Provides technical support for validation protocol.
- Implements protocols for the qualification and re-qualification of new and current instrumentation.
- Support Validation required for improvements to methods.
- Performs method and equipment validation and training.
- Organize and implement multiple projects in a collaborative team environment.
- Complete routine record review of test data.
- Supports the Quality control analytical department by identifying or troubleshooting issues that may affect laboratory or facility monitoring systems or processes and other support to daily QC operations.
- Manage reagents, data and inventory in lab and Kite Information Management Systems.
**Basic Qualifications**:
- Master’s and 2+ years of pharma experience OR
- Bachelor’s and 4+ years of pharma experience OR
- Associate and 5+ years of pharma experience OR
- High School Diploma/GED and 6+ years of pharma experience.
**Preferred Qualifications**:
- Experienced in cell and gene therapy.
- Experience in Quality Control analytical.
- Excellent working knowledge of GMP.
- Excellent background in analytical testing (Flow Cytometery, ELISA, ddPCR).
- Experience in validating various QC Analytical methods.
- Comfortable in exciting small company environment with mínimal direction and able to adjust workload based upon changing priorities.
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The salary range for this position is: $90,695.00 - $117,370.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
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