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Aurora Lifesciences has an exciting opportunity with a medical device business based in Leeds. Our client is seeking an experienced Laboratory Manager to join their growing team, which has an exciting roadmap over the next 3 years.

The successful Laboratory Manager will be joining a fast paced team and will be responsible for leading the chemistry and microbiology laboratory teams to ensure testing is carried out as required to support business and regulatory requirements. You will be using data obtained from testing to advise on potential risks, identify solutions and drive improvement.

They are looking for an experienced Laboratory Manager that has good understanding around quality and process improvement in addition to having good people and leadership skills.

Job Responsibilities

- Subject matter expert - providing technical guidance/ troubleshooting in the event of lab equipment failure, data trends, deviations or out of specification results.

- Responsible for organizing, prioritising, and executing laboratory workloads to support site operations while assuring compliance with applicable procedures, standards, and regulatory requirements, including:
• Analysis of glutaraldehyde and formaldehyde-based solutions by HPLC.
• Bioburden testing (routine and non-routine).
• Environmental monitoring programme

- Trend and use data to:
• identify non-conformance and potential non-conformance
• drive continuous improvement initiatives for efficiency and productivity in relation to lab practices, site biocontamination controls.

- Project Management

Key Skills

- Be able to critically review investigations and reports, interpret results and generate technical conclusions consistent with Quality risk management principles.

- Understanding of Quality System requirements (21CFR 820 and/or ISO13485 and/or pharmaceutical cGMP

- Hands-on analytical laboratory and/or microbiology work experience.

- Supervisory, Managerial or Project Management Experience

Benefits

- 10% Annual Bonus

- Private Healthcare

- 28 Days Annual Leave + 8 Days