QC Specialist II - Tech Services (Technical Writer)

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: August 3, 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, a Gilead Company, is seeking a highly motivated individual to join us as a QC Specialist II in the QC Technical Services group within RDMC Clinical Quality Control in Santa Monica.**Responsibilities:**+ Collaborate with cross functional team members to ensure completion of Quality records (CAPA/Deviation) or Project/validation/qualification reports and other documents on time.+ Perform job related tasks as an individual contributor under the guidance of management. Collaborate with multifunctional contributors for technical documents covering complex technical subjects.+ Conduct investigations with the support of area managers on out of specifications (OOS) results, Deviations and Environmental monitoring excursions.+ Support management in generating training documents for QC focused processes.+ Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. Represent the department in inter-departmental meetings for Change Controls and CAPA's and other quality functions.+ Prepare content including KPI's for quality meetings, conferences and presentations.+ Reviews or creates Analytical data/Process trending charts for QC processes.+ Support additional lab operations as assigned.**Basic Qualifications:**Master's Degree and 3+ years of GMP experienceORBachelor's Degree and 5+ years of GMP experienceORHigh School Degree and 9+ years of GMP experience**Preferred Qualifications:**+ Full working knowledge of GMPs, GLPs, pharmacopoeia, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.+ Background in immunology & Microbiology is highly desired.+ Experience in data trending , process monitoring , Analytical life cycle management and instrument qualification.+ Familiarity with Computer System Validation.+ High level of competency in technical writing with the ability to generate documents from scientific data.+ Outstanding organizational skills.+ Excellent interpersonal communications+ Must be flexible and able to drive deadline-driven projects to completion.+ Advanced experience in Microsoft Office, Statistical software (JMP, and quality documentation systems such as Trackwise, LIMS and AGILE.\#LI-ML1\#QCQA123Kite 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., Canada, Australia, and Singapore** **_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' (https://www.eeoc.gov/employers/eeo-law-poster) 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.

Keywords: Gilead Sciences, Inc., Santa Monica , QC Specialist II - Tech Services (Technical Writer), Other , Santa Monica, California