SomaLogic, Inc Document Control Assistant 2017-158 in Boulder, Colorado

SomaLogic, Inc.Document Control Assistant 2017-158SomaLogic is a rapidly-growing, 200-person, privately owned biomedicalscience company that has developed a revolutionary proteomics technologycapable of measuring thousands of different proteins in a single small sample.We are a dedicated team of science-based colleagues working to build new toolsbased on our technology that will change the way life science research is doneand healthcare is delivered. Come apply your document management skills tomaking healthcare better for your loved ones and the whole world.The Document Control Assistant is responsible for supporting the maintenanceand continuous improvement of the Document Control System in order to supportthe overall quality systems. This position will assist in processing androuting quality documentation, in record retention through maintaininginternal and external archive files, and other document control processes asrequired. The Assistant will assist in the maintenance of policies andstandard operating procedures to ensure regulatory compliance withstandards, guidelines and regulations (21CFR820 QSR, ISO 13485, GCP, and CLIA).Key Job Responsibilities: Process documentation changes through assisting in document changes anddocument distribution Assist in maintaining physical inventory of document control file roomsand external archives, as required File and maintain records for easy retrieval and in accordance withestablished policies, procedures and regulatory requirements Audit document control procedures to assist in process improvements fordocument control system Support maintenance of training records by filing, and updatingrecords for each employee for quality system training and other requiredelements of a quality system training record, as required by the overallquality system Develop a familiarity with the FDA Design History File requirements andthe component documents used to generate the FileEducationHigh school diploma or equivalent required; prefer Bachelor's Degree inScientific/Technical field (i.e. Chemistry, Biology, Biochemistry,Molecular Biology) or equivalent work experienceSkills and experience 3 years of experience in Document Control or equivalent education Experience with and clear understanding of the Quality SystemRegulations and ISO 13485 requirements is desired Iron Mountain off-site storage management experience preferred Experience with document management system, prefer Veeva Vault Quality Docs Proficient using Word and Excel applications and Windows operatingsystem and demonstrated ability with database applications Must be able to work effectively in a fast paced, team oriented environment Ability to work independently with minimal supervision and to workindependently with multiple departments to resolve Document Control issues Data entry with high level of accuracy Detailed oriented GXP strongly preferred Strong verbal and written communication skillsWork Environment:Work is in typical office environment but may require occasional work in atypical laboratory environment with personal protective equipment userequired.PI99304964