Within this role you will coordinate and priorities electronic laboratory data systems projects to maintain harmonization and electronic data integrity across IOPS sites and compliance with regulatory guidelines.
As a QC Electronic Data Management Specialist, a typical day might include, but is not limited to, the following:
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 environmentsContribute to the global harmonization projects of laboratory data systemsReview updates to regulatory guidelines for electronic data systems and ensure continuing complianceCoordinate 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 reportsEscalate issues, such as priority conflicts or project timeline delays, to QC managementWork with the IT LIMS and Lab System groups on projects such as defining User Requirement Specifications, execution of test plansProvide support for additional computerized systems such as: LIMS (Laboratory Information Management System) Provide training and support to QC end-usersWrite and revise Standard Operating Procedures (SOPs), User Requirement Specifications (URSs) and Functional Requirement Specifications (FRSs) with current formatsReview documents and ensure consistency with SOPs and current formats Ensures data integrity for QC systems
To be considered for this opportunity you should have a BS/BA in Life Sciences or related field and 5+ years of experience or equivalent combination of education and experience.
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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.