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Quality Systems Specialist III

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: January 6, 2022

Job Description:

Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.**For Current Kite Pharma Employees and Contractors:**Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI-/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.**Job Description**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.Kite is seeking a highly motivated individual to join us as a Quality Systems Specialist III in our clinical cell therapy production center located in Santa Monica CA. The Quality Systems Specialist III will be responsible for providing support of clinical manufacturing. In this role you will be responsible for technical oversight of Quality Systems and programs for cell therapy products. You will report to the Associate Director Quality Systems and Compliance.**Responsibilities (include but are not limited to):**+ Perform document control activities including issuance and verification of manufacturing lots+ Perform all activities around scanning and archiving documents for the site+ Represent the group at network and global meetings+ Investigate and manage deviations related to quality systems. Determine corrective/preventative actions (CAPA) and drive implementation.+ Provide ILT trainings on GDP and provide trainings as required+ Be an advocate on the new phase appropriate approach of manufacturing at the clinical site+ Generate data reports as required to be presented at Tier 4 and 5 meetings and at QMRs+ Provide Quality Systems activities and provide technical direction as needed+ Develop, revise and review SOPs and Work Instructions+ 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+ Respond to site training needs and work with the team to address these concerns+ Work close with the audit team and facilitate risk assessments for the site as needed+ Perform other duties as assigned**Basic Qualifications:**+ Master's Degree and 3+ years' experience in Quality OR+ Bachelor's Degree and 5+ years' experience in Quality OR+ High School Degree and 9+ years' experience in Quality**Preferred Qualifications:**+ The ideal candidate is familiar with analyzing and reporting results and metrics using graphical presentation.+ The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas.+ Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).+ Strong knowledge of GMP, SOPs and quality control processes.+ Strong data integrity knowledge and practices.+ Identifying, writing evaluating and closing OOS's and investigations.+ 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.**\#QCQA123**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 contact careers@gilead.com for assistance.**_Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.?_**For more information about equal employment opportunity protections, please view the 'EEO is the Law' (http://www.eeoc.gov/employers/upload/poster\_screen\_reader\_optimized.pdf) poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/ofccp/pdf/pay-transp\_formattedESQA508c.pdf)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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI-/cacheable-task/2997$2151.htmld#backheader=true) 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.**_Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S. employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. The health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority._****_The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation._**

Keywords: Gilead Sciences, Inc., Santa Monica , Quality Systems Specialist III, Other , Santa Monica, California

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