Analyst, Quality Control
- Employer
- BioMarin Pharmaceutical Inc.
- Location
- Novato, California
- Start date
- Sep 20, 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.
SUMMARY
The QC Product 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. The QC Product Analyst is responsible for providing support to activities related to sample and/or lab equipment management. The QC Product Analyst is responsible for assisting with troubleshooting work, 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. 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. Good record keeping, organizational, written and verbal communication skills are essential.
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.
- Assist in revision of written procedures as assigned.
EXPERIENCE
Required Skills:
- 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.
EDUCATION
- 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.
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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