Senior Analytical Specialist

Senior Analytical Specialist

Our client, a leading pharma & biotechnology organisation, are currently recruiting for a Senior Analytical Specialist to join their QC team in their state-of-the-art manufacturing facility, on a permanent basis.

Responsibilities

• Execute analytical procedures in accordance with current corporate specifications and cGMP’s and for maintaining the relevant SOP’s
• Build/ Maintain QCL digital systems in collaboration with site and external Digital teams
• Report results into LIMS as well as performing testing using automated systems
• Be involved in the qualification of analytical instruments and in their routine maintenance
• Develop, validate and perform verification of new methodologies, as part of new product introductions or process improvement activities
• Recognise atypical assay behavior and normally encountered equipment failure
• Be involved in deviation investigations and record any errors encountered, as per procedures and training
• Follow all relevant Environmental, Health and Safety procedures and involved in incident investigations as required
• Be responsible for the maintenance of an inventory of chemicals and supplies used to perform analytical testing
• Assist with the training of other personnel and as their level of skill develops, may be responsible for the full training of other Laboratory personnel
• May be requested to partake in or lead area or cross-functional continuous improvement projects e.g. Six Sigma or other appropriate methodology

Requirements

• Degree in Analytical Sciences (Chemistry, Biochemistry, Microbiology) with a minimum of 3 years pharmaceutical experience
• Experienced in quality control operations with an emphasis on techniques such as immunoassays, quantitative PCR, chromatography, capillary electrophoresis and spectroscopy
• Proficient in the use of multiple instrument platforms (e.g. Agilent, Beckman Coulter, Sciex, Molecular Devices, Applied Bioscience, etc.) and associated software applications (e.g. SoftMax Pro, Empower, Accuseq LIMS / LES systems)
• Demonstrated understanding of Data Integrity and its application in a Digital Laboratory
• Highly competent with computer systems
• Experience working in cross functional teams and proven ability in decision making
• Demonstrated ability in critical thinking, data analysis, problem solving and experience in root cause analysis
• Strong organizational skills, including ability to follow assignments through to completion
• Self-motivated, positive and ability to work under pressure
• Demonstrate flexibility and adaptability to meet business needs
• Excellent interpersonal and communication skills (written and oral)
• Demonstrates a continuous improvement mind-set
• Demonstrated initiative – able to work proactively without direct supervision
• Demonstrated ability to implement changes in technology and business systems / processes
• Excellent attention to detail in all aspects of the work