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QC Stability Coordinator

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BioMarin Pharmaceutical

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Location:
Ireland , Cork

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The stability and sample coordinator reports directly to the QC Manager and is responsible for coordinating the movement and storage of product related samples, as well as the coordination of stability testing in QC.

Job Responsibility:

  • Contribute to selection of intermediate and product lots produced at BioMarin for stability studies
  • Coordinate and contribute to the scheduling of stability testing in QC
  • Trend stability data and report on same
  • Prepare stability related protocols, summaries, and reports - often for direct submission to pharmaceutical regulatory agencies
  • Coordinate movement and storage of samples for testing within QC, within Biomarin and to and from contract laboratories
  • Manage the retention and reserve sample program
  • Act as technical resource (SME) and train other analysts in areas of expertise
  • Review and approve documents such as standard operating procedures, protocols, reports and track-wise documents
  • Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
  • Interact indirectly with regulatory agency inspectors during audits
  • Other duties as assigned

Requirements:

  • Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, IT, chemical or biological sciences) is required
  • Minimum 3-5 years relevant industry experience
  • Good project management skills
  • Experience in presenting to senior management
  • Lead from front attitude
  • Knowledge of regulatory guidelines and directives
  • Data orientated with good risk management understanding

Additional Information:

Job Posted:
February 13, 2026

Expiration:
February 20, 2026

Work Type:
On-site work
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