Job Description
Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 5 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard \u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.\u00A0SUMMARY: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. Global QA provides oversight on BioMarin global policies and procedures to ensure compliance with pharmaceutical regulations for GMP, GCP, GLP, and GDP. Specific areas of oversight include GxP training, quality management systems, computer software assurance, data integrity program, and supply chain quality.JOB DESCRIPTION/PROJECT:Computer Software Assurance Projects: Assess status of Quality and Technical Agreements (QTAs) with computerized system service cloud-based providers and propose plan to mitigate gaps Review and summarize BioMarin\u2019s data flows between systems to identify upstream and downstream quality data impacts for potential system issue (e.g. system outage, network outage, data corruption, etc.)Data Integrity Program:Facilitate and document Data Lifecycle Mapping workshops.\u00A0 Under the supervision of an experienced QA representative the candidate will utilize process mapping techniques and a risk analysis process to identify and assess potential data integrity risks. A great opportunity to utilize critical thinking and leadership skills! \u00A0Required Skills: Good working knowledge of MS Office applications (e.g. Word, Excel, PowerPoint) and Visio Ability to search and extract information from computerized systems for documents and records Critical Thinking skills including: Communication: Ability to understand multiple points of view and facilitate discussion that leads a group to agreement/conclusion. Analytical: Ability to examine data, understand it\u2019s significance and communicate this to others Creativity: Ability to spot patterns, and connections between ideas/data to identify potential solutions/insights.\u00A0Desired Skills: Knowledge of types of computerized system applications and platforms (e.g. document management, clinical trial management, inventory management, mobile apps, web cloud-based, local PC, etc.) Knowledge of industry software providers used by pharmaceutical companies (e.g. Oracle, Amazon, SAP, Veeva Systems, Medidata Solutions, SAS, etc.)Qualifications/Eligibility: Student pursuing a BA / BS in Computer Sciences, Biological Sciences, or associated disciplines Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the program. Must be available to work 40 hours a week Must be authorized to work in the United States without visa sponsorshipBenefits of a BioMarin Internship:Apply skills and knowledge learned in the classroom to on-the-job experiencesComprehensive, value-added project(s)Work in teams and with colleagues in a professional environment.Develop skills specific to your major.Opportunities for professional development by building relationships and learning about other parts of the business.Weekly Speaker Seminar Series with Executive Staff. \u00A0In the U.S., the hiring range for this position is $ 21.00 to $ 25.00 per hour. The base pay actually offered will take into account internal equity and also may vary depending on the candidate\u2019s geographic region, job-related knowledge, skills, and experience among other factors.PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.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.\u00A0