QC Electronic Data Management Analyst

Rensselaer, New York, US
Nov 22, 2018
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. 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 . 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 . Escalate 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 Knowledge and Skills . Excellent written and oral communication skills . Ability to prioritize, manage multiple tasks, and meet deadlines . Ability to organize and maintain data or information . Ability to learn through observation and hands on experience. Education and Experience . BS/BA in science or related field and/or equivalent combination of education and experience Level will be determined by education and experience. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.