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TEMP - Quality Improvement Specialist

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, NY, United States
Start date
Nov 26, 2020

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Job Details

As a member of the GCP Quality Improvement team, this position provides administrative and project management support. This position will provide support for the Process Deviation and CAPA Management and will assist with Quality Management System (QMOD) business administration tasks.

In this role, a typical day might include the following:
  • Manages the QMOD Business Support mailbox and provides customer support for QMOD. Works on QMOD configuration changes by helping to assess impact, and reviewing changes for business alignment to SOPs.
  • Supports Business Administration for QMOD, including minor changes in picklist values, and the communication of changes to partners.
  • Assist in the management of files and associated data/metrics supporting the Process Deviation, CAPA, and other Quality Events coordinated by the GCP Quality Improvement
  • Assist where needed with scheduling alert meetings for QMOD and Process Deviations
  • Provides support in the investigation of Quality Events as needed by tracking timelines to assure that projects are completed on time
  • Supports closure of CAPA action items, when needed
  • Disseminates essential information and status updates to management on assigned projects
This role might be for you if:

Excellent organizational skills

Working knowledge of the clinical drug development process

Proven analytical skills with attention to detail

Solid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel, Sharepoint and Outlook

Comfortable interacting with Sr. Management.

Bachelor's degree with at least one year experience in the pharmaceutical industry

Associates degree with 3-4 years' experience in lieu of Bachelor's degree.

High School diploma with 6-8 years' experience in lieu of Associate's degree.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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