Dublin, Dublin

Posted an hour ago

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Job Description

Conduct chemical and physical laboratory tests and analyze excipients, cleaning samples, raw materials,
intermediates, and final products including protocol testing in a timely manner to ensure compliance with standards and production targets.
Conduct verification of testing records and all associated electronic and hardcopy documentation.
Compile datapacks along with generation of Final CoA as necessary.
Receiving of samples into the QC Laboratory through LIMS.
Recognize and report to immediate supervisor any issues or deviations from accepted standards.
Provide status updates on own activities and productivity challenges according to defined procedures.
Ensuring that analysts working in the assigned team are performing to the best of their ability, coaching, and providing guidance where issues occur such as poor set-up or test execution performance.
Improving the overall efficiency and velocity within the assigned team.
Ensuring that the agreed test schedule is adhered to and identifying recovery paths to bring test schedules back into alignment with plant requirements.
Acting as designee for the QC Supervisor as assigned.
Acting as the primary point of contact for any analytical issues which arise.
Supporting & initiating analytical OOS issues as they arise in a timely manner through practical work.
Maintain data integrity and ensure compliance with FDA, GLP, QSR and cGMP regulations, as well as with company SOPs and specifications.
Complete and conform to all training requirements for job role, including company-required and job role-specific training.
Author documents that ensure cGMP compliance, such as laboratory investigation, deviations, change controls, change notices, analytical test methods; analytical test method development reports; method validation protocols; method transfer protocols and reports; method verifications protocols and reports; and instrumentation qualification documentation (URS/IQ/OQ/PQ).
Seek process innovation and continuous process improvement and perform quality improvement initiatives in the laboratory to meet site production goals.
Conforming to the safety culture on site on Zero, Believe it, Achieve it.
Instilling the safety culture of Zero, Believe it, Achieve it amongst the QC laboratory team
Participate in the 6S activities within the QC Laboratory.
Positively contribute to departmental goals and programs such as Right First Time
Developing expertise and understanding of current and future analytical techniques.

Skills & Technologies

LIMS cGMP GLP FDA Regulations QSR Analytical Chemistry Laboratory Testing Data Integrity Method Validation OOS Investigation

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Salary Information

Salary: $75000-105000

🤖 This salary estimate is calculated by AI based on the job title, location, company, and market data. Use this as a guide for salary expectations or negotiations. The actual salary may vary based on your experience, qualifications, and company policies.

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