QC Lab Technician

Location:  Novato, California Category: Quality Employment Category: Fulltime-Temporary

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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


The QC Global Stability Critical Material Mangement, Lab Technician, under direct supervision, is responsible for performing tasks in support of laboratory operations. The incumbent will primarily be responsible for performing stability pulls, receipt of samples for testing, sample accessioning, support testing tracking and workflow, maintain stability sample inventory, shipping samples to outside facilities, reference/critcal material inventory management, and compilation and archival of data.

 


In addition, the QC Lab Technician may perform additional duties such as;


-Data packet preparation/review


-Participation in laboratory project initiatives such as 5S


-Data entry, ordering laboratory supplies


-Participation in the maintenance of laboratory equipment through targeted preventive maintenance, and maintenance of laboratory inventory. 


-Work independently on reagent preparation that he/she has mastered in a safe and compliant manner.


-Maintains laboratory supply inventories and receives chemicals/materials into the laboratory.


-Maintains the laboratory in an inspection-ready state. Ensures reagents in the laboratory are within expiry.


-Develops familiarity concerning cGMP, 21CFR, USP, EP and ICH regulatory requirements.


-May interact with other departments, including but not limited to Manufacturing, Microbiology, Analytical Chemistry, Formulation, and Process Development.


 

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, is motivated, and organized.

Education


High school diploma or AA/BS/BA in a biological or biochemical Science. Relevant laboratory experience preferred, but not essential.

Skills and Experience


The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.

 
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.