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 25 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. BioMarin\u2019s 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\u2019s 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\u2019 lives. ROLE SUMMARYThe QC Sample Management Coordinator is accountable for operational requirements for the sample management, stability, and reserve/retention program. This position, under supervision, provides support towards the maintenance of the sample management, stability, and reserve/retention programs to achieve company objectives. The scope of the position covers both clinical and commercial programs across multiple therapeutic platforms.\u00A0 This position requires knowledge and experience with stability inventory management, sample management, reference standard, and reserve/retention programs.\u00A0 This individual is responsible to ensure that functional objectives are aligned with company goals and multi-national regulations.\u00A0 KEY RESPONSIBILITIES Perform Sample Management aspects (Sample receipt, control, and disposal of samples) Perform Stability and Reference Standard study/protocol generation Perform stability and reference standard pulls Maintain stability, lot release, reserve, retention sample inventory Perform preventative maintenance on stability/sample chambers. Perform domestic and international shipments of samples and critical materials Interacts with other departments at BioMarin on a regular basis Participation in laboratory project initiatives such as 5S, LEAN, and Six Sigma Participate in inspection readiness, regulatory inspection support and self-inspection activities. Perform Quality System attributes such as but not limited to (i.e. Minor Deviations, CAPAs, Change Controls, Action Items) Other duties as assignedNote: The QC Lab Services Sample Management Coordinator may be required to work on BioMarin holidays and/or scheduled manufacturing shut down operations to support business needs.\u00A0EDUCATION / EXPERIENCE REQUIREMENTS\u00A0Bachelor\u2019s degree in a science related field preferred Associate\u2019s degree in a science related field required 0-3 years experience in a GxP environment \u00A0SKILLSStrong communication skills \u2013 verbal and written Ability to work in a team environment which includes good conflict resolution and collaboration Eagerness to learn and develop as an individual Sound logic and decision making skillsPLEASE 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.
