Temp – QC Electronic Data Management Specialist

Recruiter
Regeneron Ireland
Employment Type
Permanent
Salary
Not disclosed
Regeneron Ireland logo

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients.

Summary: Coordinates and prioritizes electronic laboratory data systems projects (Empower, DataPro, Softmax, StatLIA, Chromperfect etc.) to maintain harmonization across IOPS sites and compliance with regulatory guidelines.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Works with cross functional teams to conduct data integrity and permission assessments
  • Work with cross-functional teams to define and prioritize electronic laboratory data systems projects and initiatives.
  • Ensure harmonization of electronic laboratory data systems use and management between laboratory environments.
  • Contribute to the global harmonization projects of laboratory data systems.
  • Review updates to regulatory guidelines for electronic data systems and ensure continuing compliance.
  • Coordinate the needs of QC functional areas and establish priorities for electronic data systems configurations, such as implementation of new specifications, design of system templates for new/revised test methods, design of queries and reports.
  • Bring up issues, such as priority conflicts or project timeline delays, to QC management.
  • Work with the IT LIMS and Lab System groups on projects such as defining User Requirement Specifications, execution of test plans.
  • Provide support for additional computerized systems such as: LIMS (Laboratory Information Management System)
  • Provide training and support to QC end-users.
  • Write and revise Standard Operating Procedures (SOPs), User Requirement Specifications (URSs) and Functional Requirement Specifications (FRSs) with current formats.
  • Review documents and ensure consistency with SOPs and current formats


Education and Experience:

  • BS/BA in Life Sciences or related field and 3+ years of experience or equivalent combination of education and experience.

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.

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