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Sr. Business Analyst or Business Analyst 2 for BioAnalytical Sciences,

Company: BioMarin Pharmaceutical Inc.
Location: San Rafael
Posted on: July 7, 2019

Job Description:

SUMMARYAs part of the Bioanalytical Operations Information Systems (BAO-IS) team, this position manages, administers, and ensures compliance of computer-related systems in the GLP-regulated BioAnalytical Sciences (BAS) department.RESPONSIBILITIESManages, administers, supports, and troubleshoots GLP-regulated laboratory computerized instruments and information systemsManages and/or supports GxP regulated change control activitiesRepresents BAS in computer systems validation (CSV) activitiesEnsures GLP and 21CFR11 compliance of computer-related instrument and information systemsAuthors and reviews SOPs related to use and administration of BAS systems, including electronic data handling and securityParticipates in internal and external inspections and auditsContributes to inspection readiness activitiesDevelops and deploys training for BAS computer systems and proceduresManages implementations and upgrades of computer systems and softwareCollaborates with internal stakeholder groups (e.g. IT-CSV, IT Business Management) in evaluating new systems in context of business and compliance needsPrepares controlled documents, process documents, and data reports including but not limited to SOPs, User Requirements Specifications, System Design Documents, System Configuration Documents, and Data Transfer SpecificationsCollaborates with BAS Managers and Scientists to improve workflow processes involving LIMS, ELN, and other BAS systemsMay be responsible for direct reports and managing workloadAny other reasonable activities or duties assigned or required by leadership or managementEXPERIENCERequired Skills:4+ years of experience supporting GxP compliant computerized systems, preferably administering Laboratory Information Management Systems (LIMS) and/or Electronic Laboratory Notebook (ELN) software6+ years of work experience in a biotech or pharmaceutical company, preferably supporting a GxP laboratoryWorking knowledge and experience with GxPs, 21CFR11, preclinical/clinical drug development and electronic data handling and securityExperience supporting computer systems validation (CSV) activites in the biopharmaceutical industry.Desired Skills:Experience with GxP documentation.Experience administering or extensive use of the following systems: Watson LIMS, Electronic Lab Notebook (IDBSELN ), TrackWise, LiveLink, SoftMax Pro, MSD, Hamilton STAR, FACSCanto, Biacore, Analyst software (HPLC / Mass Spectrometer),NuGenesis SDMSComputer systems validation in a GxP environmentExperience developing, validating, and/or performing bioanalytical test methods.Experience with at least one scripting/programming language (VBA, C#, SQL, etc.)IDBS Template developmentEDUCATIONRequired: bachelor's degree in computer or life sciencesPreferred: master's degree in computer sciences or life sciencesSYSTEMSWatson Laboratory Information Management Systems (LIMS) softwareIDBS Electronic Laboratory Notebook softwareHamilton STAR liquid handlersLaboratory instruments, computer workstations, and softwareDesktop and laptop computer workstations.Servers and related networking hardwareDatabase SystemsOperating Systems SoftwareLiveLinkMicrosoft SharePointScientific statistical software (JMP, Spotfire)CONTACTSDirectors, Managers, Scientists, and Associates, Scientists in BASScientists, Study Monitors, and Associates in Pharmacological SciencesDirectors, Managers, and Associates in BioMarin GLP Compliance.IT Quality Assurance personnelInformation Technology (IT) personnelComputer Systems Validation personnelVendors, service providers, technical representatives, and contract organizations.SUPERVISOR RESPONSIBILITYMay have one or more direct reports (business analyst and/or specialist).WORK ENVIRONMENT/PHYSICAL DEMANDSThe employee may frequently be required to sit and talk or hear.The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.The employee must occasionally lift and/or move up to 25 pounds.Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.-BIO

Keywords: BioMarin Pharmaceutical Inc., San Rafael , Sr. Business Analyst or Business Analyst 2 for BioAnalytical Sciences,, Professions , San Rafael, California

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