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QC Microbiology Analyst - Aspect Filling/Sterility

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.


SUMMARY DESCRIPTION
We are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. We are introducing a new capability for sterility assurance testing in our QC organization and are looking for micro analysts with experience in sterility testing to join our expanding team.
A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
Reporting to the QC Micro Team Leader, the primary role of the QC Micro Analyst -Sterility is to provide support to internal and external customers by providing quality testing and delivering results in accordance with GMP standards.

SKILLS/ KNOWLEDGE/ BEHAVIOURS

The role will cover Microbiological testing, including but not limited to the following:

Microbiological method verification and B&F testing in the sterility test suite.

Support for sterility testing including EM, utilities testing, BI, growth promotion, ID’s.

Perform primary review of QC raw data and trend results

Prepare protocols, summaries, and reports—often for direct submission to pharmaceutical regulatory agencies

Draft QC SOPs

Act as technical resource (SME)and train other analysts in areas of expertise

Evaluate results against defined acceptance criteria

Conduct and document laboratory investigations to completion

Maintain the laboratory in an inspection-ready state

Interact directly with regulatory agency inspectors during audits

Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary

Excellent communication skills both written and verbal

Customer focus; takes personal responsibility for speed; quality and accuracy of delivery

Self-motivated and ability to work under pressure

Team Leadership – active participation team development and continuous improvement including standard work and 5S

Successful track record in achieving goals as part of a team within a growing, dynamic environment

Demonstrated adaptability and flexibility to support a growing organisation.

EDUCATION
B.S. in a scientific discipline with 3+ years of relevant laboratory experience in sterility assurance testing.

EXPERIENCE
• Ability to work independently and meeting established timelines.
• Comfort with coordinating the activities with other staff members. 
• Comfort with working in a team environment
• Knowledge of cGMPs.


CONTACTS
Reports to Quality Control Micro Team Leader. Interacts with several departments, including but not limited to Manufacturing, Quality Assurance, Maintenance, Engineering, and Manufacturing Sciences.

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.






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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