QC Specialist II - Tech Services (Technical Writer)
Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: August 3, 2022
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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
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