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Manufacturing Documentation Associate II - 2nd Shift (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


Manufacturing Documentation Associate is responsible for managing various internal documents while also ensuring the accuracy, quality, and itegrity of documented entries. This role requires the individual to receive, review, edit, and/or format various controlled documents and production batch records. Documentation review will occur with both in-process ducuments and with documents within BioMarin's electronic system. All document reviews and revisions must comply with established procedures.

Skills


Successful candidate MUST:




    • Have a high level of attention to detail and strong verbal/written communication skills

    • Have experience performing batch record and controlled form review

    • Have experience processing documentation in an administrative capacity

    • Have the ability to prioritize tasks in a fast-paced environment

    • Have an intermediate level of proficiency in MS Word and MS Excel (including headers/footers, page formatting, templates, and creation of step numbering)

    • Ability to become familiar with BioMarin electronic systems (Trackwise, Pi, CMMS, etc)



Education


B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.


Associates degree with 2+ years of related experience


High School degree with 4+years of related experience



Experience:



4+ years of directly related industry experience, including review of production batch records and/or controlled forms



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.

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