QC Documentation Support - TEMP

SUMMARY:The individual is responsible for authoring, reviewing Quality Control technical documents, including Specifications, Test Methods (ATM), Monographs and Standard Operating Procedures as necessary, to ensure alignment with current FDA regulations, ICH guidelines, USP methodologies, GMPs, and SOPs. The individual is also responsible for tracking CAPAs. ESSENTIAL FUNCTIONS:Include the following. Other duties may be assigned.Authors, reviews, QC Chemistry technical documentation, such as Specifications, Test Methods (ATM), Monographs and Standard Operating Procedures as necessary.Represents QC Chemistry, as a member of CAPA Review Board.Update QC Chemistry documentation by initiating or reviewing Change Control Requests and Documentation Change Requests.Track CAPAs and perform actions as necessary to address the CAPA timely. Updates the Trackwise and/or Veeva with all the necessary information and determine that the CAPA is ready for approval.Coordinates with QA CAPA team to address the comments and close the CAPA timely.Executes all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, GMP''s and SOP''s.Performs work independently and with minimal supervision.Any other duties as assigned

Created: 2021-11-29