Overview
The Analytical Laboratory Analyst will be required to assist the Team Lead, Analytical Laboratory in the day to day running of the Analytical Lab.
Reporting to: Team Lead, Analytical Laboratory
Find out more about Cook Medical here
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.
* 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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