QA Specialist (Oligonucleotides/VLPs)

We are currently looking to fill a Quality Assurance Specialist (Oligonucleotides/Virus-like particles (VLPs)) position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

In this role, a typical day might include the following:

+ Reviewing and approving batch records from Contract Manufacturing Organizations (CMO) manufacturing bulk drug substance including VLPs and small interfering RNAs (si-RNA)
+ Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
+ Providing consultation or advice in alignment with QA policies
+ Performing activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.)
+ Re...