QA Specialist (Oligonucleotides/VLPs)

Overview 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. Responsibilities 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 investigations associated with raw materials, product, laboratory, facilities, and materials Performing status labeling of raw materials and product Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement Qualifications Associate QA Specialist – 2+ years QA Specialist – 4+ years Sr QA Specialist - 6+ years May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. 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. Salary Range (annually) $62,355.00 - $128,700.00 #J-18808-Ljbffr Regeneron