QC Technical Writer

Support Laboratory Quality Systems including change control, investigations, deviations, events, SOP revisions, and documentation practices as part of the quality and compliance objectives.Conduct investigations related to quality systems such as deviations, events, NCRs, CAPAs, OOS, NOEs, complaints, and Quality Protocols of high complexity; works closely with other members of the organization during investigations to determine root cause and potential preventative/corrective actions.Author and review investigations and proposed CAPAs, investigational protocols and reports ensuring conclusions and actions are appropriate for the identified root cause.Responsible for the timely closure of investigations and quality records and filing extensions as neededAuthor and review stability protocols and reports, Analytical protocols and reports, SOPs, audit responses, and other documents as needed.Support review of analytical methods and specification creation and revisionsGuide assigned personnel in conducting thorough, compliant laboratory investigations.Coordinates with QC laboratory personnelProvide weekly summaries of lab incidents and investigations to the Senior Manager and Director.Communicate activities and status on laboratory investigations as required.Responsible for improving and conducting training in analytical techniques, documentation, and regulations, especially those connected with laboratory investigations.Handles and completes special projects as required.Ensure Data Integrity.Supports attainment of team leader goalsWork with Microsoft Excel, Word, and possibly PowerPointParticipate in document change control process as needed to maintain document audit readiness/compliance.Working with laboratory CAPA owners to ensure that quality records remain current and present updates at Quality Council meetings.Process document changes and management of changes while ensuring good documentation practices (GDP) within the eQMS system.Other duties as assigned.