Business Systems Analyst 2 / Sr. Business Systems Analyst

Location
San Rafael, California
Posted
Jul 06, 2021
Ref
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Required Education
Bachelors Degree
Position Type
Full time
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.

By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY

The Business Systems Analyst 2 / Sr. Business Systems Analyst in the Information Management department at BioMarin Pharmaceutical Inc. will provide application support and implement software that meets the User Requirements and long-term goals/strategy of the QC department. The Analyst will help ensure systems are implemented efficiently following a standard process so that the lab is delivered systems that enhance compliance, improve efficiency, and reduce regulatory risk.

RESPONSIBILITIES

  • Provide Post-Go live system/application support of QC enterprise and standalone systems
  • Gather software specific requirements and draft SDLC documents
  • Organize project meetings, and perform standard meeting organizer duties (agenda, minutes action items etc.)
  • Research system/software functionality to determine suitability and its capability of meeting user requirements
  • Drive the team towards improved technical solutions to ensure data integrity
  • Configure software using standard out of the box tools and GUI to meet specific lab process requirements
  • Communicate to System Owner and user how the software meets their requirements
  • Assist in the development of Risk Assessments by providing software/system specific expertise
  • Draft preliminary test cases for IQ/OQ/PQ protocols
  • Draft SOPs, work instructions and other training materials
  • Document, and communicate project outcomes (Positive/Negative) to management and participate in effort to constantly improve the process
  • Assist in ad hoc projects as needed to address deviation investigations or initiatives.
  • Mentor junior staff
  • Educate System Owner regarding compliant software and business process choices that ensure data integrity is maintained

 SKILLS/EXPERIENCE

Must Have:

  • High level knowledge of Empower to support the application
  • Ability to plan and prioritize assignments effectively to meet timeline commitments
  • A strong desire to implement solutions that solve pressing compliance and process problems
  • 3-5 years in a regulated industry (preferably Pharmaceutical/Biotech, Medical Devices or Healthcare industries)
  • Strong interpersonal communication skills including, formal presentations, meeting management, negotiation/persuasion and conflict resolution
  • Clear verbal and written communication skills to provide customers with a positive experience
  • Self-motivation, and be a quick learner of business processes and technology
  • Firm understanding of GMP predicate rules, 21CFR Part 11/EU Annex 11, and Data Integrity concepts

 Desired:

  • Experience implementing or supporting common QC software solutions (e.g. SoftMax Pro, WinKQCL, Chromeleon, ELN, etc)
  • Experience as a software business administrator
  • 2 years bench level laboratory experience
  • 4 years direct experience implementing/validating software in a regulated environment
  • Experience managing projects
  • Experience in generating SDLC deliverables particularly URS, FRS and Config Spec 
  • Experience/Knowledge of good requirements gathering techniques including process mapping techniques. (LEAN, SIX SIGMA)
  • Experience initiating and managing Change Control, and Deviations requests with TrackWise
  • ASQ, PMI, ITIL certifications

EDUCATION

  • BA/BS degree in either Life Sciences or Computer Science/MIS related degrees ~ Or a minimum of 8 years direct experience in a similar role with escalating levels of responsibility will be considered

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