Overview
QC Analyst Jobs in Waterford, County Waterford, Ireland at Recruitment by Aphex
Title: QC Analyst
Company: Recruitment by Aphex
Location: Waterford, County Waterford, Ireland
Purpose
To provide comprehensive analytical chemistry services and technical support to the Site Quality Control laboratory. This role ensures the accurate, compliant, and timely testing of raw materials, intermediates, and finished products to facilitate batch release and maintain the highest standards of quality.
Responsibilities
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Perform a range of analytical techniques including ELISA, UV/VIS Spectroscopy, Osmolality, Oxygen Headspace analysis, SDS-Page, Biacore (receptor binding), Moisture (Karl Fischer), and Particulates (HIAC).
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Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ).
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Maintain, update, and issue chemical methods, specifications, and SOPs to ensure compliance with pharmacopoeial and regulatory requirements.
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Audit and review chemistry test results on a daily basis to ensure strict compliance with cGLP and cGMP.
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Check and audit laboratory notebooks and analytical reports for accuracy and completeness.
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Ensure all quality documentation and records are complete and current.
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Conduct OOS (Out of Specification) investigations in a timely manner and document results on Certificates of Analysis (COAs).
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Ensure QC laboratories meet current Good Laboratory Practice (cGLP) requirements at all times.
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Interact effectively with other departments (Quality Assurance, Production, Engineering, and Planners) regarding matters related to raw materials, intermediates, and finished batch releases.
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Update the QC Team Leader on potential problems and highlight process improvements through normal communication channels.
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Assist with the training of fellow analysts in areas of expertise, and in the implementation of new methods, SOPs, and updates.
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Trend analytical results and maintain records on COAs as required.
Requirements
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Proven experience working in a GMP/GLP regulated Quality Control environment.
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Strong understanding of Pharmacopoeial and Regulatory requirements.
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Excellent attention to detail and strong documentation skills.
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Demonstrated ability to conduct OOS investigations effectively.
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Instrumentation: Proficiency with Softmax, Karl Fischer, HIAC, UV/VIS.
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Techniques: Excellent micro-pipetting technique, ELISA, Osmolality, Oxygen Headspace, SDS-Page, and Biacore.
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Validation: Experience with equipment qualification (IQ, OQ, PQ).
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Software: Experience with Softmax software is highly beneficial.
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Strong organizational and time management skills (good timing skills).
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Effective communication skills for cross-functional collaboration.
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Ability to work independently and as part of a team.
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Proactive approach to problem-solving and improvement.
