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Intern - QA CSV & Data Integrity

Location Novato, California
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 BioMarin Summer Internship Program will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, while gaining an insight into the pharmaceutical/biotech industry.

JOB DESCRIPTION:

Data Integrity Program at BioMarin supports BioMarin’s compliance with data integrity regulatory expectations. As part of Data Integrity process improvements activities, the data lifecycle management process will provide a solid methodology on how to manage data cumulative risks throughout a system lifecycle.  Technical solutions will be translated into procedures and will be applicable to new and existing systems for TOPS.  Specifically, Audit Trail Reviews are to be executed according to new SOPs revisions and process improvement deliverables. This project will improve the overall data integrity maturity level at BioMarin by meeting the established requirements per regulatory guidance and internal procedures.

RESPONSIBILITIES

  • Identification of Audit Trail Reviews per area, per system category.
  • Identification of Audit Trail review reports scope and frequency.
  • Assist in the execution of audit trail review reports for Computer Systems Lifecycle.
  • Support Data Integrity Program project management deliverables at BioMarin. 

QUALIFICATIONS/ELIGIBILITY:

  • Experience in Quality Assurance, Information Management, Computerized System Validation and/or Compliance.
  • Comfort working and communicating in a dynamic, multi-disciplinary, collaborative research environment.
  • Excellent organizational skills and demonstrated ability to accurately complete detailed work.
  • Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the intern program. 
  • Must be available to work 40 hours a week.
  • Housing and Transportation is responsibility of the Intern.

Required Skills:

  • Good verbal and written communication skills.
  • Technical Skills: 
    • Microsoft office (excel/word/outlook/project/powerpoint);
    • Computer software;
    • Computer programming/software code.

Desired Skills:

  • Familiarity with Biotechnology and Pharma processes.
  • Familiarity with FDA and EU pharma regulations (GxP), as well as good documentation practices.
  • Familiarity with probability and risk management tools.
  • Familiarity with Information Technology/Information Management (servers, clouds, data management).

Benefits of a BioMarin Internship:

  • Apply skills and knowledge learned in the classroom to on-the-job experiences
  • Comprehensive, value-added project(s)
  • Work in teams and with colleagues in a professional environment
  • Develop technical skills specific to your major
  • Provides opportunities for professional development by building relationships and learning about other parts of the business
  • Weekly lunch seminar series with Executive Staff
  • End of summer poster presentation to the BioMarin Community  

EDUCATION

  • BS - Engineering or Information Management Major - Undergraduate (Junior or Senior year)

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.

About our location

Novato

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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