QA Specialist (Oligonucleotides/VLPs)

Job description

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.) Reviewing, editing, or approving Regeneron controlled documents Reviewing and approving of investigations associated with raw materials, product, laboratory, facilities, and materials Performing status labeling of raw materials and product Co...