QA Officer, Contract Testing/ Nicotine.
Location: Colne, Lancashire
Salary: Competitive DOE plus additional benefits
Our client, a multi sited and expanding CT / CRO Company are looking to recruit for a QA Officer to work at their modern/ new complex. This opportunity has come about through growth and client demand; this is a fantastic opportunity for a candidate who has had exposure to extended QA duties (CAPA, OOs, deviations etc) to move into a full time QA position! This company has a great working culture and has experienced significant growth since the opening of this new site.
The role will involve, but not limited to:
To support quality activities within our Clients Nicotine Services department 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 Client Nicotine Services to support continuous improvement activities.
- Will hold a Degree in a relevant Scientific discipline
- Extended QA experience in a GLP setting (CAPA, OOs, and Deviations etc); UKAS Contract Testing backgrounds will be considered.
- Strong interpersonal skills, with the ability to liaise with multiple departments