QC Analyst
Novato, CA
Job Title: Quality Control Analyst Employee Type: FTE Location: Novato, U.S.A. \u00A0 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 Quality Control Analyst, under direct to minimal supervision, is responsible for providing support to the on-time release, stability and non-routine testing of the pharmaceutical drug substances and drug product in a cGMP environment.\u00A0 The Quality Control Analyst is responsible for providing support to activities related to sample and/or lab equipment management.\u00A0 The Quality Control Analyst is responsible for assisting with troubleshooting work and supporting training to QC and Contract Test labs.This position requires willingness to undergo training on more advanced analytical methods and employs laboratory safety policies at all times.\u00A0 Work assignments will encompass performing and documenting activities from routine to non-routine samples, and requires the ability to recognize deviations from the accepted practice. The analyst will be responsible for the timely completion of all assignments.\u00A0 Good record keeping, organizational, written and verbal communication skills are essential. Role Responsibilities Performs, under direct to minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines. Evaluates data against defined criteria/specifications. Assists in the revision of written procedures as assigned. Works independently on assays that he/she has mastered. Develops and maintains proficiency in a broad range of trained test methods. Trains other analysts in areas of expertise. Maintains the laboratory in an inspection-ready state. Maintains laboratory supply inventories. Ensures that support for glassware cleaning and other routine laboratory functions/chores for the QC laboratory are met to meet business needs, such as lot release, method transfers, and validation studies. Develop familiarity concerning cGMP, 21CFR, USP, EP, and ICH regulatory requirements. Interacts with other departments at BioMarin as appropriate. Holds self and others responsible to abide by department and company policies and practices. Assists in revision of written procedures as assigned.Education Required B.S./B.A. in Science (major in biology-biochemistry-chemistry). 2-3 years of relevant laboratory experience, or A.S. with at least 4 years of relevant laboratory experience is desired.Experience Required At least one year in a cGMP/GLP laboratory; quality control experience is preferred. Ability to follow written instructions and to perform tasks with direct or minimal supervision. Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel. Good written, verbal, and communication skills. Good documentation skills. Demonstrates the ability to work independently.Supervisor Responsibility Not applicable to this positionBehavioral Competencies Accountability Achieving Excellence Communication Courage / Challenge Develop Self & Others Judgement Reliability TeamworkTechnical GMP Acumen Critical Thinking & Evaluation\u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0\u00A0 Organizational\u00A0Awareness\u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 Self-Knowledge\u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0 \u00A0Note: 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. 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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