QA Specialist

Summary:
A QA Specialist is required for a biopharmaceutical company in West Dublin.

Responsibilities:

• Support the global supplier and material approval processes including migration of site-based processes to the global process.
• Support management of Quality Agreements.
• Support Supplier Change Notification process to ensure appropriate change control and regulatory updates have been made prior to making changes.
• Support monitoring of approved Suppliers through data gathering and reporting.
• Support periodic review of approved Suppliers.
• Gather data and report quality metrics for internal processes and identify and implement improvement opportunities.
• Support Continuous Improvement of the Supplier Quality System.
• Support audits and inspections, as appropriate.
• Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.

Qualifications & Experience:

• B.Sc. or equivalent in Biological Sciences, Chemistry, Microbiology or other science.
• Minimum of 4+ years’ experience in Quality with medical device, pharmaceutical, or biologics experience.
• Experience in Supplier Quality, Material Qualification, Procurement, Quality Assurance, or Auditing.
• Experience with Quality Risk Management and Structured Problem-Solving tools.
• A strong customer focus and ability to prioritize and adapt to business needs.
• Knowledge of applicable international GXP regulations and standards.
• Strong business partner with a focus on delivering results.
• Excellent written and verbal communication skills.
• Experience with high performance teams, cross functional projects.
• Experience with Technical Writing.
• Experience working with mature supplier quality system.
• Previous global Quality System development/deployment experience.
• Experience supporting regulatory inspections.