QC Analyst - 1st Shift
- Employer
- BioMarin Pharmaceutical Inc.
- Location
- Novato, California
- Start date
- Jun 15, 2021
View more
- Discipline
- Quality, Quality Control
- Required Education
- Associate Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay, Best Places to Work
Job Details
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.
Duties
Sun-Wed or Wed-Sat
The 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.
SkillsSkills
- QC 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.
Education
Bachelor 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.
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.
Company
BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.
Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.
Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.
- Website
- https://www.biomarin.com/
- Location
-
California
United States
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