QA Documentation Specialist to Support QMS Inspection Readiness

LogisticsAssociate Level20 hours per week for 3 monthsRemote, ideally from East Coast to support East Coast and EU based teamsTravel Requirements: N/AHourly rate: $70 - $120AboutClora's client is a clinical-stage biotechnology company focused on treating and preventing chronic diseases of aging, is building the medicines that will redefine healthcare in the 21st century – therapeutics to extend healthspan, the period of life spent in good health. The client is looking for a QA documentation specialist to support preparations for QMS inspection readiness. 2-3 month engagement, around 20 hours per week.ResponsibilitiesIdentify and collect all documents and system documentation that constitutes the Quality Management System (QMS), including but not limited to current and historic controlled documents and annexes to those; GxP relevant policies; audit plans and reports; up to date vendor list, vendor qualification and selection documents; training matrix and records; CVs, job descriptions, org charts; and other system description.Propose adequate storage and maintenance processes to ensure accessibility and foster understanding of the QMS across the organization to ensure compliance with the client's QMS.Review all documentation for fit for purpose state and support training for functional heads and their direct reports how to access and maintain documentation about the QMS.Ideal CandidateBachelor degree or relevant professional experience5 years experience in administration and maintenance of stage-appropriate Quality Management Systems, including early stage development small organizationsExperience with regulatory inspectionsUnderstanding of GxP documentation compliance covering at a minimum GMP, GCP and GLP.Excellent communication skillsDetail oriented and meticulousCustomer-oriented, experience communicating changes and new processes to internal and external stakeholdersProactive, self-starter who is comfortable in a fast-paced start-up environment