Sr. Business Analyst or Business Analyst 2 for BioAnalytical Sciences, Research
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.
- 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
- 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.
- 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
- Required: bachelor’s degree in computer or life sciences
- Preferred: master’s degree in computer sciences or life sciences
- 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
- Microsoft SharePoint
- Scientific statistical software (JMP, Spotfire)
- 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.
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.