Job Title: Quality Assurance Specialist
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This is an exciting opportunity to join a leading organization in Carlow, Ireland.
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As a Quality Assurance Specialist, you will play a key role in ensuring the quality and compliance of our products through cGMP and corporate regulations.
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* Maintain data integrity by adhering to ALCOA principles for records and data.
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* Liaise with QC Leads to resolve quality-related queries as needed.
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* Develop and implement adequate processes and procedures for all quality activities.
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* Support manufacturing and release activities in compliance with applicable procedures and regulatory requirements.
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* Identify and support compliance initiatives to improve operational efficiency.
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* Contribute to business-critical projects related to the Quality Department.
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* Apply MPS principles and tools to identify continuous improvement opportunities.
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* Provide quality support for controls and procedures throughout the material and product lifecycle.
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* Assist team members with qualification/validation, technical transfers, and commercial operations as needed.
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* Support laboratory and team members with day-to-day activities.
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* Ensure compliance with regulatory requirements.
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* Assist with SOPs, deviations, cleaning verification/validation data, and other documents as necessary for the Quality and Manufacturing departments.
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* Contribute to writing/revising/rolling out accurate operational procedures, training materials, and maintenance procedures for various Quality related systems.
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* Strong understanding of cGMP and corporate regulations.
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* Excellent communication and interpersonal skills.
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* Ability to work independently and as part of a team.
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* High level of organizational skills.
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* Proficiency in MS Office applications.
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* Knowledge of ALCOA principles.
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* Experience in a similar role or industry.
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* Understanding of MPS principles and tools.
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* Quality management system knowledge.
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Benefits:
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* Competitive salary and benefits package.
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* Ongoing training and development opportunities.
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* Opportunity to work in a dynamic and innovative environment.
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* Collaborative and supportive team culture.
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* Flexible working arrangements.
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Others:
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* Reporting directly to the Quality Manager.
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* Working closely with cross-functional teams.
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* Participating in regular meetings and training sessions.
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* Contributing to the development of new processes and procedures.
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* Providing support for audits and inspections.