Quality Officer

Ashberry Recruitment are looking for a Quality Officer for one of our Earby based clients. Our client provides analytical testing to the E-cigarette industry globally. They analyse devices and e-liquids and provide data on safety and product quality. The facility is a member of the GLP Compliance Monitoring Programme and works to ISO17025:2017.

The Quality Officer is principally responsible for supporting quality and laboratory operations within our client’s services. This is carried out by aiding the management of the day-to-day quality and compliance functions of the business to provide commercial analytical laboratory services for the Electronic Nicotine Delivery System (ENDS) industry.

Key Tasks & Accountabilities

• To support quality activities within our client’s services in compliance with GLP regulations and ISO17025 accreditation
• To conduct internal/supplier audits to ISO17025 and GLP standards
• To perform quality/technical support to the operational teams using sound hypothesis and investigational judgment for the completion of out of specification, out of trend, non-conformance and deviation records
• To perform quality/technical documentation review and approval of product and technique based analytical test methods
• To perform quality/technical review and approval of test method development, test method assessment and test method validation protocols and reports in accordance with ICH Guidance
• To provide support with business activities relating to the effective validation and qualification of equipment and computerised systems in accordance with regulatory requirements and data integrity
• To support routine laboratory operations in delivering timely, accurate Quality Assurance results using LIMS
• To maintain Key Performance Indicators (KPI) for monitoring, managing, and improving the performance of the Quality Management System
• To plan and execute quality projects within Broughton Nicotine Services to support continuous improvement activities
• Adhere to company policy and procedure e.g. Dignity at work, Health & Safety, ALCOA
• Any other duties as required to fulfil business goals

Education & Experience

• Preferred Graduate of Chemistry, Quality or a related subject – Appropriate industry experience also accepted
• Analytical experience of working in a commercial laboratory with working knowledge of various laboratory techniques such as; Karl-Fischer, related substances testing, HPLC – UV, LCMS, GCMS, ICP-MS, IC
• Experience of overseeing out-of-specification/out-of-trend investigations, root cause analysis would be an advantage
• Experience of performing risk assessment activities
• Experience of review and approval of technical documents; protocols, reports, technical summaries
• Experience in the interpretation of analytical data (such as chromatograms and spectra) would be an advantage
• Understanding of statistics; such as %RSD, moving ranges, confidence intervals etc
• Knowledge of data integrity with regards to MHRA/FDA expectations
• Good knowledge of COSHH and health and safety
• Excellent attention to detail for review and approval purposes
• Good working knowledge of GLP and/or ISO17025 quality systems
• Laboratory Information Management Systems (LIMS) knowledge would be advantageous
• Capable of working as an individual and team player
• Good analytical and technical problem-solving skills
• Confident verbal reasoning skills with colleagues and customers
• Good IT skills
• Results driven, customer focused and commercially astute