North Yorkshire | Permanent | Competitive Package + Bonus + Pension
Are you a skilled professional looking to join our Quality Assurance Team?
Do you have a scientific background with an excellent working knowledge of quality management systems within a GMP environment? Are you looking to further your career within a highly regarded pharmaceutical contract testing facility?
Broughton Laboratories Limited is an independent contract analytical laboratory based on the stunning Broughton Hall Business Park servicing the pharmaceutical and healthcare industries. An opportunity to join the Broughton Laboratories Quality Assurance team has arisen, and we are looking for a successful candidate to be a key figure in helping deliver further success to our clients.
In line with expansion we are seeking to recruit hard-working, highly motivated and professional individuals capable of working within a fast-moving quality laboratory environment. As a Quality Assurance Officer in the Quality team you will be responsible for performing quality management system maintenance activities, Quality Control batch release approvals and host client audits, under the guidance of the Quality Manager.
Main Purpose of the Job
- To perform quality management system maintenance activities within Broughton Laboratories to GMP regulations.
- To perform routine client audit activities, hosting, response and corrective actions.
- To support routine laboratory operations in delivering timely, accurate Quality Assurance results by certificate of analysis using LIMS.
- 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 conduct internal/supplier audits to GMP and company standards.
- To perform quality/technical review and approval of test method assessment, test method development, and test method validation protocols and reports in accordance with ICH Guidance.
- To provide support relating to the effective validation and qualification of equipment and computerised systems in accordance with regulatory requirements and data integrity.
- 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 Laboratories 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.
Key Person Specification
- Preferred graduate of Chemistry/Analytical Chemistry, Science or Quality related subject.
- Experience of working within a GMP Quality Management System environment for 3+ years, or
similar regulated setting.
- Good technical problem-solving skills, attention to detail, verbal reasoning and negotiating skills.
- Experience of working with both Quality and Operational Systems would be advantageous;
Laboratory Information Management System (LIMS), Quality System database for Non-Conformance, Out of Specification/Out of Trend, Complaints, CAPA.
- Good IT skills including working knowledge of Microsoft applications.
- Good working knowledge of Analytical chemistry within a GMP regulated laboratory is desirable but not essential.
- Capable of working individually and as a team player.
- Confident verbal reasoning skills with colleagues.
- Results driven, customer focused and commercially astute.
- Experience of chromatography, theory and practise would be advantageous but not essential.
- Experience of performing failure investigations and Root Cause Analysis (1+ years).
- Experience of data reporting would be advantageous but not essential.
- Experience of training and developing others in a lab environment.
Broughton Laboratories provides exciting opportunities for you to apply your knowledge, skills and experience through hands-on assignments and projects. You will work alongside the best Scientists within the industry. Each year, Broughton invests in learning and development offering you a competitive salary, pension, supportive leadership team and tailored training programme. Join our team to discover your potential and take pride in valuable achievements.
Broughton Laboratories is a privately-owned global analytical services business. We are an FDA and MHRA inspected laboratory focused on delivering a high-quality service for industry-leading clients across the pharmaceutical, animal health, medical device and electronic nicotine delivery industries. Whether its innovation or optimisation, Broughton Laboratories tackles the toughest challenges from new product development to fast-paced routine Quality Control.