QC Analyst

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. 
 

PURPOSE


The QC In-Process department is responsible for performing select microbiological and analytical test methods on in-process intermediates and varying stages of drug products, under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics.


 


Job Duties:



    1. Primary role will be timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.

    1. Execute microbiological and/or analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.

    1. Perform environmental monitoring sampling and testing of facilities, equipment, and utilities.

    1. Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.

    1. Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments, and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.

    1. Assist with monitoring and the control of laboratory supply and critical reagent inventories.

    1. Perform growth promotion of media and microbial identification testing.

    1. Qualify as trainer for specified methods, provide training to less experienced staff.

    1. Provide on call coverage to support oversight of QC laboratory equipment functionality.

    1. Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.

    1. Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.

    1. Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.

    1. Perform other responsibilities as deemed necessary.


 


Qualities:


We are seeking a candidate who is self-directed, has the ability to work independently and is highly-motivated. The QC analyst will often work in a fast-paced and deadline driven environment, so it's important they can stay focused and carry out their tasks in a timely and accurate manner. They should be detail-oriented, dependable and trustworthy since they come in contact with complex and sensitive documents.

Skills


The QC analyst should have the ability to prioritize, manage time well, multitask and troubleshoot. Strong interpersonal, communication and customer service skills are also essential because the QC analyst will regularly communicate with internal and external business partners.


 


Must have excellent record keeping, written and verbal skills.


 


Ability to perform most tasks without supervision.


 


Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices is a plus.


 


Able to lift up to 25lbs


 


Computer literacy is required, proficiency with Microsoft Word and Excel is essential.


 


Must have excellent record keeping, written and verbal skills.


 


Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.


 

Education


Bachelor of Science in a Biological or Biochemical Science with at least 0-2 years of relevant


laboratory experience


 
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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.