Senior Associate Quality Control

Elanco; Liverpool; On-site; GBP 30,000 - 45,000; Full time

Job summary

A global animal health company based in Liverpool is seeking a laboratory-based professional for its Analytical Service Centre. The role involves executing analytical work for characterizing reference standards, with responsibilities covering method development, validation, and documenting in GMP-compliant reports. Applicants should have a BSc in Chemistry and strong GMP laboratory experience, particularly with HPLC. This position offers a standard 7:30 hour workday, Monday to Friday, and encourages a diverse applications process.

Qualifications

• Strong working knowledge of GMP analytical laboratory operations with at least 5 years of experience.
• 5-10 years of practical experience of HPLC analysis in a GMP Lab.
• Ability to communicate effectively with auditors.

Responsibilities

• Perform characterization testing using various analytical techniques.
• Document results in GMP compliant reports.
• Conduct laboratory investigations and deviations.

Skills

GMP knowledge

HPLC analysis

Analytical method development

Problem solving

Documentation

Education

BSc in relevant Chemistry discipline

Tools

HPLC

GC

NMR

Veeva

Job description

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

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status