Scientist I, Quality Control (Quality Support)

This position is a hybrid role and will report on site to our RTP location minimum of 3 days per week (subject to change based on business needs)About This Role  A Scientist I in the quality control (QC) reference standards and qualified materials (RSQM) team is responsible leading key functional, tactical, strategic aspects for RSQM activities and issues associated with small molecule (SM), antisense oligonucleotides (ASO), or biological programs. This individual manages multiple programs/projects within RSQM and drives initiatives related to the technical and strategic aspects while working independently. The Scientist I performs QC activities associated with overall RSQM philosophy including inventory, shipping, sourcing new materials, qualification of materials, extension of materials, exceptions, and review of documents. They are responsible for preparing & approving technical protocols/reports pertaining to use of RSQMs, and ensures all work is carried out in a cGMP manner, with adherence to regulatory expectations. What You’ll Do  Act as a program manager/project lead for multiple programs/projects within RSQM and drive initiatives for RS or qualified material activities (technical, tactical, strategic) independentlyAuthor, review, and approve controlled GMP documents, protocols and reports, change control requests, risk assessment, regulatory documents required to support QC business & compliance & methodologyParticipate or lead continuous improvements projectsSolve technical issues related to RSQM materialsParticipate as an effective member of cross-functional teams as a representative of the QC RSQM. Apply holistic quality system approach through identifying and solving technical issues and identifying areas for improvement or remediation related to qualityOther duties as assigned