Quality Control Leader, In Vitro Diagnostics
Our client has developed an affordable, end-point PCR system that can serve as the basis for rapid detection, quantification, or drug resistance testing of infectious diseases and pathogens. With the continuing growth of the company, a need has been identified for this pivotal role in the smooth transfer of products from R&D into Manufacturing and then to Customers, taking place within a Quality Management System supporting IVD regulatory global compliance.
They are looking for a QC Leader to join their Operations Team. You will play a key supporting role across various areas of the business providing strategic direction & expertise on quality issues in manufacturing in relation to in-process QC testing, coordination with R&D for the adoption of QC methods for new and incoming products and post sale vigilance. You will be expected to plan the workload, lead and train a small team whilst also working at the laboratory bench when required.
Report to the Operations Manager this role will undertake the following duties:
- Act as the Subject Matter Expert in relation to QC processes in relation to regulatory and client audits
- Incoming component & product sub-assembly release control.
- QC of lifecycle of materials - supporting component and product stability studies
- In-process QC testing and release plus post-sale vigilance
- Undertake trend analysis of data - tracking & deviation identification
- Support company-wide technical development and manufacturing projects as required
- Collaborate and maintain strong leadership links with IVD Project Teams to ensure productive and regulatory compliant development and design for manufacture
- Represent the Operations Team on cross-functional product teams by taking responsibility for QC activities to support R&D and Regulatory submissions
- Liaise as necessary with our company-wide Quality Assurance and Regulatory colleagues & management
- Leadership of QC Operations Technicians and membership of the wider Operations Team with responsibilities in support, training, task planning and resource allocations
- A science graduate, ideally with post-graduate qualification in a relevant discipline.
- You will have experience in industry or health service laboratories with evidence of leadership.
- Experience of leading a team and working safely in a laboratory environment.
- You will have experience of working in a regulated product manufacturing environment to ISO 13485 –Medical Devices and Good Laboratory Standards (GLS).
- Experience of Quality Control processes in IVD development
- You will have experience of writing Standard Operating Procedures (SOPs) and working to them on a daily basis.
- Practical laboratory experience with molecular diagnostic (PCR) reagents and products
- You are proficient in real-time PCR techniques and data interpretation.
Location: North West England
Salary: Negotiable + Benefits
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