Business Analyst/Senior Business Analyst

Location:  Novato, California Category: Quality

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives. 
 

SUMMARY

The Business Analyst works with the Quality Control laboratory to identify software-related change needs and ensure they are met. Primary focus is on user requirements capture, solution/change impact assessment, and solution selection/prioritization for local (site) benchtop laboratory systems. Fundamental purpose of the job is to ensure business requirements are identified, met, and users understand how they are met.

This position requires experience working in a GxP environment.

 RESPONSIBILITIES

  • Represent/champion/mediate on behalf of business during local benchtop system validation lifecycle & change activities (provide guidance to business on adequacy of requirements/specifications and testing)
  • Elicit and document local benchtop system user requirements, ensure the user understands how the system meets their needs
  • Collaborate in the planning and deployment of new applications and enhancements to existing local benchtop system
  • Implement Data Integrity content and controls into local benchtop system SOPs
  • Execute local benchtop system periodic and audit trail reviews
  • Elicit/document/analyze the current state of system business process; assess current capabilities
  • Define the ‘Data Lifecycle’ for local benchtop systems and identify associated GxP risks and mitigations
  • Develop scenarios for User Acceptance Testing (UAT) and facilitate end-user testing
  • Update business procedures as needed to reflect process changes
  • Drive change control activities for local benchtop system changes
  • Drive consensus and resolve conflicting interests across project team members/stakeholders
  • Senior Business Analyst may also assist with routine global enterprise system tasks as assigned
  • Other duties as assigned

 EXPERIENCE

Required Skills:

  • 1-4 years of relevant business analysis experience gathering/analyzing/testing requirements
  • Minimum of 3 years in the biotech/pharma industry
  • Working understanding of GxP guidelines including 21 CFR Part 11
  • Communication Skills – must be able to facilitate working meetings, ask good questions, listen to the answers, and absorb what’s being said
  • Problem-solving Skills – must be able to facilitate a shared understanding of the problem, the possible solutions, and determine the scope of the project
  • Critical Thinking Skills – must be able to evaluate multiple options and help team settle on a solution
  • Documentation/Technical Skills – must be able to create clear, accurate, and concise documentation
  • Relationship-Building Skills – must be able to forge strong relationships built on trust
  • Self-Managing – must be able to manage the business analysis effort and yourself to commitments and deadlines

Desired Skills:

  • GxP laboratory environment experience
  • Experience with GxP documentation
  • Prior relevant experience with application of software solutions
  • Super-user level understanding of laboratory analytical software
  • Experience using TrackWise and HP ALM (Application Lifecycle Management)

 EDUCATION

  • B.S. in a science/engineering discipline, minimum

EQUIPMENT

Computers, lab equipment & analytical software

 CONTACTS

Project team interaction with internal departments (QC, QA, Validation, Information Technologies)

 SUPERVISOR RESPONSIBILITY

None

 
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.