Document Control Specialist - Location: Frederick Maryland USAFrederick Maryland United StatesJob Type: regular full-timeDivision: Precision for MedicineBusiness Unit: Specialty Lab ServicesRequisition Number: 3624Position SummaryThe Document Control Specialist will be responsible for the maintenance and management of controlled documents and records for Precision for Medicine as well as provide administrative support to the quality assurance team.

　　Essential duties include but are not limited to:

　　Quality Assurance, Document Control - General

　　Facilitate the electronic document control process regarding new or existing Quality System Documents, and other related records, and tracking the status of documents during their life cycle: draft, peer review, approved, effective, retired / obsolete, etc.Work with owners/originators, reviewers and approvers to facilitate document control workflow, ensuring proper document formatting and organizationEnsure right-first-time review prior to formal review process, by quality management, to ensure good documentation practices, readability (clear and concise) and compliance with internal standards. This includes reporting gaps to senior management and providing guidance to document owners regarding how to create, remediate or correct documentsAssist with Quality Systems Procedure revision as part of an integration process: keeping track of originating procedures and the new / integrated procedures as well as all related documents (manuals, forms, flowcharts)Assign training workflows for new or revised quality system procedures and for new employeesMaintain document securityCoordinate Periodic Review of Documents to ownersUpload existing/new revision documents to the PLN portal or Precision PLN sitesTraining

　　Conduct training for new and existing employees on electronic quality management system.Audits

　　Locate, review, submit, and reconcile document/record requests during auditsEnsure timely response to documentation requests for auditsPrepare welcome packet folders for upcoming auditsUpdate procedure binders for upcoming auditsPrepare Dossiers on Employees Training Binders that are selectedOther duties

　　Raw Material (RM) label requests, communicating and coordinating with departments, reviewing requests and printing RM labelsOther duties as defined by managementQualificationsMinimum Required:

　　High School Diploma or equivalent combination of education and experienceOther required:

　　1-3 years of experience with ISO 9001/13485 standardsObtain Document Control certification within first yearAbility to meet deadlines and perform administrative functionsMicrosoft Office suite proficiencyMust be a flexible agile team player who can change activities and directions quickly and respond to a variety of assignments and changing business needs.Ability and willingness to travel between locations when business needs dictateMust possess a valid driver's license allowing you to drive in the state(s) you drive inAble to travel both domestically and internationally including overnight staysMust be able to read, write, speak, fluently and comprehend the English languagePrecision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.

　　Reasonable estimate of the current rang

　　$21.50- $28.50 USD