Analyst, QC I

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


Responsibilities:


The Quality Control Analyst, under direct or minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability samples.  The Analyst works independently on assays that he/she has mastered.



The Analyst will be responsible for performing, under direct or minimal supervision, sample testing compliant with cGMP guidelines to meet specified timelines.  This position required willingness to undergo training on more advanced analytical methods and employs laboratory safety polices at all times.  Work assignments will encompass performing and documenting activities from routine to semi-routine in nature, evaluates data against defined criteria/ specifications, trends, and require the ability to recognize deviations from the accepted practice.  The analyst will be responsible for the timely completion of assignments, maintains laboratory supply inventories, and maintains the laboratory in an inspection-ready state.  Good record keeping, organizational, written, and verbal communication skills are essential.  The analyst must be willing to work overtime and weekends as required, and expected to spend between 80-90% of his/her time in the laboratory.


 
The analyst is required to develop and maintain proficiency in a broad range of trained test methods, assists in the revision of written procedures as assigned, assists in the preparation of routine and non-routine study protocols and reports, and trains peers in areas of expertise.


 


Equipment:


The analyst must develop skills in the operation and routine maintenance of various analytical instruments and computers. The analyst must develop the skills necessary to understand the operation of the equipment and gain knowledge of the equipment used for testing and to use these skills to work with their supervisor/manager in the event of an unexpected result caused by equipment or reagent failure that warrants a laboratory investigation.

Skills


Desired Skills:


Familiarity with cGMP, LabWare LIMS, CMMS, and/ or TrackWise.

Education


Education:


B.S./B.A. in Science (major in biology-biochemistry-chemistry) with 0-3 years of relevant laboratory experience


 

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.