SanRafaelRecruiter Since 2001
the smart solution for San Rafael jobs

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

Company: BioMarin Pharmaceutical Inc.
Location: San Rafael
Posted on: August 5, 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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Professions Jobs


Postmates Part Time Delivery Driver (Supplement Your Income)
Description: Postmates uses technology to connect local businesses with people around the city. Our fleet receives requests through the app, and delivers anything from anywhere, 24/hrs a day. We are
Company: Postmates
Location: Manteca
Posted on: 08/21/2019

Uber Driver Partner
Description: Drive with Uber and earn money anytime it works for you. Driving is an easy way to earn extra, and it's totally flexible around your schedule. You decide when and how much you drive.What you need to know: (more...)
Company: Uber
Location: Sunnyvale
Posted on: 08/21/2019

Forklift Operator (US) Tracy CA WERC (Tracy, CA)
Description: Virtual Job Tryout: After completing your application, DHL Supply Chain asks that you also complete a Virtual Job Tryout VJT . The VJT provides a realistic job preview to each applicant allowing you (more...)
Company: Deutsche Post DHL Group
Location: Tracy
Posted on: 08/21/2019


Local CDL-A Driver - 1+yr EXP Required
Description: Opportunities Available for Local CDL-A Truck Driver Benefits ul li Sign on bonus available depending on location ask for more details li Daily Home Time li Competitive salary li Supplemental (more...)
Company: Hub Group Trucking
Location: Tracy
Posted on: 08/21/2019

Supervisor, Inventory / Merchandising
Description: Supervisor, Inventory / Merchandising Job Category Store Leadership Location Number -Tracy-Store Job Description Our Merchandise Inventory Supervisor will execute strategic plans in merchandising, (more...)
Company: Best Buy Co
Location: Tracy
Posted on: 08/21/2019

Local Truck Driver- Class A CDL
Description: br br br CALL Britteny 888 816-2983 NOW for immediate consideration. We only have a few spots left open. br Route Details: bull Home Daily bull 58,000 to 65,000 yearly bull Monday- Friday (more...)
Company: Drive On
Location: Manteca
Posted on: 08/21/2019

Postmates Part Time Delivery Driver (Supplement Your Income)
Description: Postmates uses technology to connect local businesses with people around the city. Our fleet receives requests through the app, and delivers anything from anywhere, 24/hrs a day. We are
Company: Postmates
Location: Ceres
Posted on: 08/21/2019

Postmates Delivery Driver (Part Time / Full Time)
Description: Postmates uses technology to connect local businesses with people around the city. Our fleet receives requests through the app, and delivers anything from anywhere, 24/hrs a day. We
Company: Postmates
Location: Manteca
Posted on: 08/21/2019

WAREHOUSE ORDER SELECTOR - Tracy
Description: Warehouse Order Selector- No experience necessary starting salary up to 17.50 per hour up to 25.15 per hour with excellent benefits. Apply at: joinmclane.com/tracy Enter
Company: McLane Pacific
Location: Tracy
Posted on: 08/21/2019

Supply Chain Project Analyst
Description: Supply Chain Project Analyst North America-North America-United States-CA-Sunnyvale POSITION SUMMARY: Supply chain planning leadership at Sunnyvale Facility Established methodologies with proven cross (more...)
Company: Leica Biosystems
Location: Sunnyvale
Posted on: 08/21/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Rafael RSS job feeds