External Quality Associate 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


 


We are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.


 


A high-level of initiative, energy, and motivation are key role requirements, as well as organizational skills and the ability to motivate others.


 


The External Quality Associate 1 reports to the External Quality Manager and is responsible for supporting Quality Systems related to operations, product specification change controls and batch release processes.  This position requires interaction with multiple levels in Quality, Regulatory Affairs, Manufacturing, Supply Chain, Materials Management, and Contract Manufacturing Operations.


 


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 individuals 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.

Skills


KEY RESPONSIBILITIES


 



    • Create and/or revise product specification documents, following MAA, BLA, CTA, IND and/or IMPD filings, in BioMarin's controlled document management system (Veeva).

    • Initiate and set-up change control workflows for product specification revisions in Veeva and BioMarin's quality management system (TrackWise).

    • Coordinate TrackWise and Veeva change control workflows for review and approval of product specification revisions.

    • Monitor and ensure document implementation timelines.

    • Monitor backlog in associated trackers.

    • Generate custom Certificates of Analysis to support lot release, new market applications, annual product reviews, and/or market renewals.

    • Ensure all individual training and group-specific guidelines are kept current.

    • Provide assistance with training new staff.


EXPERIENCE


 



    • Minimum 3-5 years of experience in a Quality, Compliance, and/or Regulatory setting.

    • Strong attention to detail, organization and communication skills.

    • Ability to maintain organization of a large volume of data in a systematic manner

    • Proficiency with computer systems (Microsoft Office Suite).

    • Proficiency with eQMS (TrackWise), LIMS, Oracle EBS, eCDMS (Veeva) and Office365 preferred.

Education



    • Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical engineering, chemical or biological sciences) is required.

  • Advanced degree preferred.

 
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.