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Gilead Sciences, Inc. Document Issuance Specialist in Hoofddorp, Netherlands

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

We are seeking a highly motivated individual to join us as a Quality Systems - Document Issuance Specialist reporting to the Quality Systems Document Control Senior Manager. You will work in Quality Assurance team in supporting our efforts in this exciting new area of cancer immunotherapy. You will be responsible from preparing the batch specific document package for manufacturing operations and as well as issuance of other controlled documents. You will work closely with Manufacturing Planning to ensure readiness of documents timely and right first time.

Responsibilities (include but are not limited to):

The Quality Systems Document Issuance Specialist will use Kite’s Electronic Document Management System and enterprise resource planning (ERP) to issue controlled documents and labels.

Additional job duties include:

  • Responsible for the management of all document issuance and archival processes to support GMP operations.

  • Issue effective documents including procedures, test methods, specifications and batch documentation.; including final product labels.

  • Issue logbooks.

  • Ensure accuracy and completeness of QA issued documents.

  • Identify and escalate compliance gaps across the document management system

  • Execute strategic initiatives to improve the document management system.

  • Support investigation of deviations against the document management system and develop effective corrective action plans.

  • Support audits (internal, external)

  • Perform other duties as required to fulfill department and business needs.

  • Role requires shift availability during weekends.

Working location is Hoofddorp.

Requirements:

  • 2+ years of relevant experience in a GMP environment related field and a BS or BA.

  • Prior experience in pharmaceutical industry, cell therapy, biologics, blood/human tissue, or vaccines experience preferred.

  • Demonstrates good interpersonal, verbal and written communication skills, which are essential in this collaborative work environment.

  • Working knowledge of electronic documentation systems, data retrieval, and electronic file formats.

  • Detail oriented with solid problem-solving acumen.

  • Ability to work effectively in a team environment.

  • Ability to analyse and reconcile moderately complex issues.

  • Must have demonstrated initiative and accountability in a fast-paced environment.

  • Proficient with computers and word processing software (i.e. Microsoft Office products).

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 .

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

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.

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