Analyst, QC Microbiology\/Environmental Monitoring (Swing Shift)
Novato, CA
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 – 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’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. Shift: Swing shift, Wed to Sat, 1230pm-11pmThe Quality Control Microbiology, Environmental Monitoring, Analyst I under direct supervision, is responsible for performing microbiological, biochemical, and chemical evaluations of the manufacturing facilities, utilities, and equipment. With experience they would perform as a back-up for QC In-process and QC Microbial ID testing.Under direct supervision, the incumbent will be primarily responsible for performing environmental monitoring sampling and testing of the facilities, equipment, and utilities under cGMP guidelines. In addition they will be responsible for performing biochemical and microbiological assays of samples under cGMP and GLP guidelines. Work assignments will encompass activities from routine to semi-routine in nature with the ability to recognize deviations from accepted limits and practices. The incumbent will be responsible for completing assignments in a timely manner, for assisting with troubleshooting, assisting with data trending, and for follow-up on any testing issues or excursions. Good record keeping, organizational, written and verbal communication skills are essential. Functional activities could include: supporting process validation studies, contributing to investigations, method validations, assay method/procedure development, reagent preparation, in-process microbiological and analytical testing, growth promotion of media, and microbiological identification testing. The position requires knowledge of, but is not limited to, aseptic technique, microbial challenge studies, bioburden determination, microbiological method validation, endotoxin, protein, activity, TOC, and other similar analysis methods. The incumbent must be willing to work second shift, overtime, weekends, and holidays as required. SkillsQC cGMP experience beneficial. • Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices. • Demonstrated working knowledge related to specific functional activities. • Ability to perform most tasks with supervision. • Computer literacy is required. • Experience with Microsoft Word and Excel required; experience with Access and PowerPoint a plus. • Must have excellent record keeping, written and verbal skills. • Experienced with microbiological methodologies and a variety of analytical instrumentation; capable of troubleshooting assays. Efficient in scheduling and facilitating the execution of routine and non-routine testing.EducationBachelor of Science or Bachelor of Arts in a Biological or Biochemical Science with at least 0-2 years of relevant laboratory experience or Associates of Science with at least 4 years of relevant laboratory experience 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.
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