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

Location San Rafael, California

SUMMARY

As 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.

RESPONSIBILITIES

  • Manages, administers, supports, and troubleshoots GLP-regulated laboratory computerized instruments and information systems
  • Manages and/or supports GxP regulated change control activities
  • Represents BAS in computer systems validation (CSV) activities
  • Ensures GLP and 21CFR11 compliance of computer-related instrument and information systems
  • Authors and reviews SOPs related to use and administration of BAS systems, including electronic data handling and security
  • Participates in internal and external inspections and audits
  • Contributes to inspection readiness activities
  • Develops and deploys training for BAS computer systems and procedures
  • Manages implementations and upgrades of computer systems and software
  • Collaborates with internal stakeholder groups (e.g. IT-CSV, IT Business Management) in evaluating new systems in context of business and compliance needs
  • Prepares 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 Specifications
  • Collaborates with BAS Managers and Scientists to improve workflow processes involving LIMS, ELN, and other BAS systems
  • May be responsible for direct reports and managing workload
  • Any other reasonable activities or duties assigned or required by leadership or management

EXPERIENCE

Required Skills:

  • 4+ years of experience supporting GxP compliant computerized systems, preferably administering Laboratory Information Management Systems (LIMS) and/or Electronic Laboratory Notebook (ELN) software
  • 6+ years of work experience in a biotech or pharmaceutical company, preferably supporting a GxP laboratory
  • Working knowledge and experience with GxPs, 21CFR11, preclinical/clinical drug development and electronic data handling and security
  • Experience 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 (IDBS ELN), TrackWise, LiveLink, SoftMax Pro, MSD, Hamilton STAR, FACSCanto, Biacore, Analyst software (HPLC / Mass Spectrometer), NuGenesis SDMS
  • Computer systems validation in a GxP environment
  • Experience developing, validating, and/or performing bioanalytical test methods.
  • Experience with at least one scripting/programming language (VBA, C#, SQL, etc.)
  • IDBS Template development

EDUCATION

  • Required: bachelor’s degree in computer or life sciences
  • Preferred: master’s degree in computer sciences or life sciences

SYSTEMS

  • Watson Laboratory Information Management Systems (LIMS) software
  • IDBS Electronic Laboratory Notebook software
  • Hamilton STAR liquid handlers
  • Laboratory instruments, computer workstations, and software
  • Desktop and laptop computer workstations.
  • Servers and related networking hardware
  • Database Systems
  • Operating Systems Software
  • LiveLink
  • Microsoft SharePoint
  • Scientific statistical software (JMP, Spotfire)

CONTACTS

  • Directors, Managers, Scientists, and Associates, Scientists in BAS
  • Scientists, Study Monitors, and Associates in Pharmacological Sciences
  • Directors, Managers, and Associates in BioMarin GLP Compliance.
  • IT Quality Assurance personnel
  • Information Technology (IT) personnel
  • Computer Systems Validation personnel
  • Vendors, service providers, technical representatives, and contract organizations.

SUPERVISOR RESPONSIBILITY

May have one or more direct reports (business analyst and/or specialist).

WORK ENVIRONMENT/PHYSICAL DEMANDS

The 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

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San Rafael

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