Business Analyst 2 or Sr. Business Analyst, BioAnalytical Sciences, Research
San Rafael, CA

Job Description

Business Analyst 2 or Sr. Business Analyst, BioAnalytical Sciences, Research Location San Rafael, California Apply

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