Job Title: Quality Specialist
Job ID: 61657BR
Location: Warrington, UK
We have an exciting opportunity for an enthusiastic individual with previous experience in a quality environment to join our organisation as a Quality Specialist. You will be based at our Warrington site which is part of the Genetic Sciences Division (GSD) where we manufacture human identification forensic kits which are used to process biological evidence collected in criminal investigations for judicial systems in countries worldwide.
In this fast-paced role you will provide focus for the Global Quality Management System working closely with manufacturing and other departments /functions to support, develop and promote consistency, continuous improvement and compliance with Global/Site quality and business requirements. You will be responsive and proactive in identifying and managing risks to assure product availability and ongoing customer satisfaction. You will take initiative and drive change across the business in order to promote both compliance and efficiency.
Duties and Responsibilities:
- Recognise that decisions taken have both local and global implications which will in turn influence the Quality Management System and the processes and practices applied.
- Closely interacts and builds effective relationships with people across site to promote quality, consistency and compliance.
- Provides quality support to manufacturing and NPI projects.
- Demonstrates courage and willingness to determine appropriate action and make risk-based, sound and timely decisions. Ensures and maintains compliance with internal and external (ISO18385/ISO13485 etc) standards and regulatory requirements.
- Identifies and drives improvement opportunities with areas through effective communication and ensures where quality issues arise that root cause is determined and the appropriate actions are agreed and implemented. Manages corrective and preventive action processes ensuring the timely and accurate resolution of problems identified.
- Takes responsibility for the measuring and monitoring of performance against agreed KPI's.
- Collates and shares information/data and trending as appropriate through reports and follows up on improvement opportunities.
- Actively participates and/or drives EU/Global QMS improvements as required. Actively contributes to the success of the overall QA team and the site. Identifies, advises and implements training/coaching to meet defined Quality Systems requirements.
- Performs/takes part in internal audits and external audits as required according to site and global plans.
- Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate.
- Takes responsibility for ensuring timely completion and follow up through to closure.
- Participates in personal development to further enhance skills and knowledge relevant to the position. Supports and maintains Company's Safety, environmental and Waste Management programmes.
- Degree in a scientific discipline or equivalent experience in a relevant discipline.
- Knowledge of ISO9001/13485/ISO18385 or equivalent standards.
- Experience with Quality Improvement Tools (5 Why/pareto analysis/Run Charts).
- Experience of CAPA (corrective and preventive action) processes & problem solving within CAPA multi-functional teams.
- Ability to work on multiple tasks at any one time.
- Excellent communication and report writing skills.
- Ability to recognise deviation from requirements and understanding risks when decision making.
- Experience of office packages and general computer skills
- Ability to challenge existing approaches to compliance in order to seek improved ways of working.
- Ability to coach and influence others is essential.
- Quality Assurance experience in a chemical/biological or pharma manufacturing industry.
- Experience with cGMP (current Good Manufacturing Practice) is essential.
- Experience with electronic quality tools an advantage e.g. Trackwise/Agile.
- Experience with ERP systems an advantage i.e.SAP.
- Experience of verification and validation processes and statistics based quality tools.