Job Title: Lab Analyst - Analytical Test Methods (Medical Device)
Location: On-site, Limerick
Contract Type: Contract
Reason for Hire: Increased capacity due to the validation of a drug-delivering medical device
Overview:
A leading medical device manufacturing company is seeking a highly skilled Lab Analyst to support the validation process of a drug-delivering medical device. This 12-month contract role will be based on-site in Limerick, and we are looking for a candidate with strong expertise in Analytical Test Methods, particularly in HPLC and Dissolution Testing. This position is critical in supporting the validation efforts and ensuring the integrity of test results in accordance with Good Manufacturing Practice (GMP) standards.
Key Responsibilities:
* Perform and support the validation of analytical methods for a drug-delivering medical device.
* Conduct HPLC (High-Performance Liquid Chromatography) and Dissolution testing to ensure the quality and consistency of products.
* Work in compliance with Good Manufacturing Practice (GMP) and adhere to internal standard operating procedures (SOPs).
* Prepare, document, and analyze test results, ensuring accuracy and compliance with regulatory requirements.
* Assist in the preparation of validation reports, ensuring comprehensive documentation of all analytical processes and results.
* Collaborate with cross-functional teams to provide technical support and expertise in analytical test methods.
* Maintain and troubleshoot lab equipment, ensuring it is properly calibrated and in good working order.
* Ensure safety protocols and good laboratory practices are followed at all times.
Requirements:
* Degree in Chemistry, ideally with a PhD.
* Minimum of 2 years' experience working in a GMP-regulated environment within the medical device or pharmaceutical industry.
* Strong hands-on experience with Analytical Test Methods, particularly HPLC and Dissolution testing.
* Solid understanding of validation processes and the ability to support drug-delivering medical device development.
* Ability to work in a fast-paced environment while maintaining a high level of attention to detail.
* Strong communication skills, both written and verbal, for effective documentation and reporting.
* A proactive, problem-solving attitude and the ability to work independently as well as part of a team.
Desired Skills:
* Experience with other analytical techniques (e.g., UV-Vis Spectroscopy, FTIR) would be an advantage.
* Familiarity with ISO 13485 or other medical device quality systems.
* Ability to troubleshoot and resolve analytical instrumentation issues.
* Experience in a regulated environment for medical device or pharmaceutical testing.
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