QA Document Control Specialist

Cork
Permanent
Full-time

6 days ago

DescriptionWho We AreBioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists, and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Cork, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.About Technical OperationsBioMarin'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.QADC Specialist- Shanbally, Ringaskiddy, Cork - onsite role12 month contractPOSITON SUMMARY:The Quality Assurance Document Control (QADC) specialist is responsible for maintaining and continuous improvement of site quality systems, providing quality oversight of the facility with a focus on document management quality system.RESPONSIBILITIES:

Process site-controlled documents on the site Document Control System.
Approve document change controls and establish document effective dates.
Complete work according to established priorities and policies to assure product documentation is delivered on schedule.
Support and train other staff members on the implementation of global improvements related to the Document Control System.
Train and support other staff members on the use of the Document Control System.
Maintain the Sites Document Store and escalate any potential issues.
Control and issue controlled document numbers as required.
Support Inspection Readiness for the site and the site in preparation for upcoming inspections.
Examine the Quality Metrics related to the Document Control System.
Participate and support Continuous Improvement for the Quality Team.
Other duties may be assigned as requested.

EDUCATION/EXPERIENCE:
Strong communication and organisational skills required.Experience with QMS and EDMS systems is desirable.Experience with excel / metrics generation is desirable.Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.Equal Opportunity Employer/Veterans/DisabledAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

BioMarin

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