Intern, Quality Compliance

2 weeks ago

Novato, United States BioMarin Pharmaceutical Full time
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations 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. 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. Over the course of 10 - 12 weeks our interns gain industry experience while working alongside our talented team on meaningful projects. The Quality Compliance team is accountable for all GMP compliance activities for the Novato site. The team leads the site in compliance and inspection readiness activities by designing, enhancing, and implementing processes to ensure compliance with regulations, health authority expectations, maintain a state of permanent inspection readiness, and ultimately driving to maintain our right to operate. JOB DESCRIPTION/PROJECT: This role provides the opportunity to gain insight into the Compliance aspect of GMP manufacturing. Areas of involvement include the following: Support the improvement of standard business tools in areas of inspection readiness and compliance Exploring the use of advanced tools like artificial intelligence to transform processes such as risk management, compliance knowledge management, and metric analysis Partner with process owners to implement improvements to business processes such as regulatory certifications, annual product review, self-inspection, and quality management review Partner with cross-functional teams to support a state of permanent inspection readiness at the Novato site Interpret 21CFR, USP, EP, JP and ICH regulatory guidelines and directives Required Skills: Strong written, verbal, and interpersonal skills Desired Skills: Competency with statistical analysis tools such as Excel, Power BI, as well as artificial intelligence tools Effective project management skills are a plus Qualifications/Eligibility: Student pursing a BS/BA in a scientific discipline or related field Must be available to work full time, 40 hours a week. Must be currently enrolled as a full-time student at an accredited U.S. based university or college and enrolled in the fall term after the completion of the internship OR have graduated within 1 year of the start of the program. Must be able to relocate if necessary and work at the designated site for the duration of the internship for on-site, hybrid roles. Some positions will be open to remote interns, but employee must be within United States borders. Benefits of a BioMarin Internship: Paid hourly wage, paid company holidays, and sick time Apply skills and knowledge learned in the classroom to on-the-job experiences Comprehensive, value-added project(s) Develop skills specific to your major. Opportunities for professional development by building relationships and learning about other parts of the business. Participate in company all hands meetings, monthly community lunches Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks Access to Employee Resource Groups Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. In the U.S., the salary range for this position is $ 21 to $25 per hour, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

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