Analytical Laboratory Analyst 2

Analytical Laboratory Analyst 2

Cook Medical

Limerick, Ireland

Responsibilities

• Deputize for Team Lead, Analytical Laboratory as required including providing technical and problem-solving support to the team as required;
• Aid in the development of new methods and conduct testing and software validation activity as required;
• Carry out project work as required, particularly associated with the implementation of new specifications and methods of analysis required to comply with pharmacopeia or customer requirements;
• Review/Approve Qualification of equipment used in the lab;
• Perform analytical testing in accordance with associated regulatory and procedural requirements and ensure that laboratory documentation is kept up to date at all times;
• In depth knowledge of Agilent HPLC’s, Empower, Pharmspec and Chemstation Software required;
• Receipt and log-in of samples for testing;
• Daily monitoring and verification of laboratory equipment and completion of associated paperwork;
• Perform instrument calibration and maintenance and review and approval of associated documentation as required;
• Review/Approve laboratory testing data as required and reports for release testing of finished product and raw materials analysis;
• Review and Approve laboratory investigations in a timely manner as required;
• In depth knowledge of Agilent HPLC’s, Empower, Pharmspec and Chemstation Software required;
• Laboratory purchasing and inventory control as required;
• Maintain laboratory in a clean and well organised status at all times;
• Delegate for Microbiologist where trained on relevant procedures/tasks;
• Participate in audits (internal and external) and inspections and implement CAPA outcomes as appropriate;
• Comply with GLP/GMP and safety requirements at all times;
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

• Candidates must possess a third level qualification (degree level) in chemistry/science related discipline;
• The ideal candidate should possess at least 3 years’ experience in a GLP/GMP analytical laboratory environment within the pharmaceutical or medical device industry;
• Candidates must be strong technically with the ability to troubleshoot HPLC, and/or dissolution in addition to other analytical instrumentation. Candidates must be capable of working on their own initiative and also be comfortable within a team environment;
• Willingness and availability to travel on company business.

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