Senior Associate-Quality Control

locations: UK - Speke

type: Full time

posted on: Posted Today

job requisition id: R0024577

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Your role:

This is a laboratory-based position within the Analytical Service Centre (ASC) laboratory. The role involves the execution of the analytical work required for the characterization of the Elanco reference standard portfolio. This will include some analytical method development, fit for purpose method qualification/validation, execution of compendial and non-compendial test methods, solution stability studies and generation of other analytical data as needed. In addition, the role also includes analytical method remediation/improvements, validation and transfer supporting manufacturing/customer supply, commercialisation, quality and regulatory aspects of the business.

Your responsibilities:

• Perform reference standard characterization testing using a variety of analytical techniques (IR, HPLC/UPLC, KF, NMR) documenting results in GMP compliant reports
• Use appropriate scheduling and planning to ensure reference standard work is executed within agreed timelines
• Performing analyses and appropriately documenting results to support method remediation and method verifications/validations/transfers to GMP standards.
• Employ good GMP documentation practices to thoroughly and accurately document all work in a timely manner
• Use problem solving/troubleshooting skills to investigate laboratory issues and identify root causes
• Execute and document laboratory investigations, deviations and change controls using an electronic Quality Management System (Veeva)
• Maintain laboratory and office areas in compliance with EHS and cGMP requirements.
• Perform all aspects of Sample/Ref Std handling, eg receipt, storage and disposal as per procedures.
• Conduct laboratory equipment calibrations and maintenance.
• Write, update and review SOPs, validation protocols and reports
• Follow lab purchasing procedures to ensure laboratory remains sufficiently stocked with standards/reagents and consumables.
• Complete all mandatory training within expected timelines and ensure you are trained before performing any laboratory task.
• Communicate with internal and external auditors (eg Elanco corporate auditors, FDA, VMD, etc) in accordance with company policy and procedures.

What You Need to Succeed (minimum qualifications):

• BSc or equivalent in a relevant Chemistry discipline
• Strong working knowledge of GMP analytical laboratory operations achieved by at least 5 years experience of working in such an environment
• 5-10 years of practical experience of HPLC analysis in a GMP Lab
• Experience in performing GC, IR and Karl Fisher analyses
• Ability to work collaboratively as well as independently to achieve goals
• Self starter with excellent written and verbal communication

What will give you a competitive edge (preferred qualifications):

• Previous experience of using Waters integration package (Empower)
• Previous experience of using an electronic document management system
• Practical experience of executing method validations (especially for LC methods)
• Analyses using Nuclear Magnetic Resonance (NMR) equipment
• Dissolution Testing

Additional Information:

• Work schedule 7:30 hour days Monday to Friday on site