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QA Document Control Specialist (TEMPORARY)

Location Cork, Ireland
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

Maintain all aspects related to controlled document mastering, issuance, distribution and storage in a GxP environment, including Commercial and Clinical batch records, SOPs and forms.
Maintain technical agreements with external service providers.
Maintain technical reports.
Oversee employee training on GDP and the electronic document system.
Coordinate external document storage activities and maintain related contracts.
Participate in internal and external compliance audits as related to QADC activities.
Participate in periodic routine reviews of controlled documents.
Maintains and reports relevant performance and compliance metrics
Actively participate in teams standard work and 5S activities.
Support relevant electronic system initiatives related to QACC.
Assist with the development of cGMP training specific to manufacturing, documentation, investigations and current regulatory requirements in the manufacture of drug substance.
Other duties as assigned.

Skills

2+ years experience in a cGMP regulated manufacturing environment with exhibited knowledge or proficiency in Document control and related systems

Good knowledge and understanding of GMP requirements and guidelines

Proficiency with technical summary report generation required, with exceptional organizational and Computer skills preferred.

Education

Minimum of a college or university diploma. Equivalent experience may be considered.

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

Cork

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