Senior Clinical Analyst

Job ref: SCA111024 Job type: Permanent Location: Newry Closing date: Friday 25 Oct 2024 17:00 The successful candidate will form an integral part of the GLP Clinical study analytical team and will conduct bioanalysis, supervise & train/upskill analytical staff. They will support Laboratory Management to deliver project analytical phases and maintain the laboratories, equipment and personnel in audit ready status. Working within our state of the art laboratories, the successful Senior Clinical Analyst will be innovative and bring ideas to help increase the efficiency of the laboratory and procedures. They will be highly motivated, demonstrate an applied knowledge of regulatory guidelines and display excellent analytical technique with high levels of accuracy and precision. Main Activities/Tasks Perform and oversee the extraction of drug actives from biological matrices using existing analytical methods to support PK and residue analysis as outlined in the relevant study protocol and in accordance with the Good Laboratory Practice (SI3106). Supervise analysts within the clinical laboratories. Assist in the training and development of new and existing analytical team members. Conduct investigations and root cause analysis within the laboratory. Identify and contribute to the assessment of deviations, CAPA planning and delivery. Oversee and/or carry out validation and maintenance tasks on laboratory equipment as required Assist in the checking and compilation of laboratory records, Prepare/review/revise Standard Operating Procedures and Analytical Reports as required, Assist Laboratory Management to ensure the laboratory and equipment are maintained to an excellent standard, always adhering to GLP guidelines. Drive safe working practices within the laboratory, following COSHH and Health & Safety requirements. Essential Criteria: A relevant Biochemistry, chemistry, biology or other applicable Science based degree, A minimum of 3 years' U/HPLC experience within a GXP Laboratory environment, 2 years' experience in the training and supervision of laboratory analysts, Expertise in the conduct of Solvent and Solid Phase extractions (SPE) of drug actives from biological matrices, 2 years' experience in Root Cause Analysis of Laboratory OOS Investigation and implementation of resulting CAPA, Excellent oral & written communication skills, Excellent knowledge of Microsoft Word & Excel software packages. Desirable Criteria LCMS/MS experience within a GXP Laboratory environment Expertise troubleshooting relevant laboratory equipment, HPLC, UPLC etc. Experience with compiling Laboratory Documentation including Change Controls, Deviations, Risk Assessments and COSHH. Bring innovative ideas to help the day to day running of the laboratory and the on-boarding for new laboratory personnel. Additional Information: Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered. We regret that applications received after the closing date and time will not be accepted. Contact: Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community. To Apply Please forward your CV via the APPLY Now button below.