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QC Lab Technician (TEMPORARY)

Location Novato, California
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 technician will be responsible for the preparation of the reagents used for sample testing by following Standard Operating Procedures (SOPs).compliant with current Good Manufacturing Practices (cGMP) guidelines. This position requires a willingness to undergo assay specific reagent preparation training for a variety of analytical methods and to follow laboratory safety polices at all times.


The individual must demonstrate good documentation and organizational skills. Good written, and verbal communication skills are essential for this position. The technician must be willing to work overtime and weekends as required.

Additional job responsibilities include:

Preparation of reagents for biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.

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

Responsible for washing and stocking laboratory glassware used for analytical assays.

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.

Provides support for routine laboratory functions/chores for the QC laboratory such as monitoring temperature charts, cleaning water baths and/or laboratory refrigerators/freezers/ storage cabinets where reagents are held.

Assists in the revision of written procedures as assigned regarding reagents and/or reagent management.

Compilation and archival of data

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


The QC technician should have an Associate Degree or should be working towards a degree. One year of laboratory experience is desired.

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.

About our location

Novato

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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