* Job Title – Microbiology Manager
* Location – Deeside
* Contract Length – Perm
* Pay Rate – 60k
Key Responsibilities
* To act as a technical expert on behalf of the organisation by providing advice, guidance, and expertise on microbiological issues.
* Actively manage the microbiology laboratory team, including effective engagement, communication, recruitment, and employee development.
* Responsible for managing the microbiology testing programme. Ensure all microbiological testing, methods and validation exercises reflect applicable regulations/guidelines and meet industry best practice.
* Accountable for meeting targeted KPI’s and monitoring team performance; maintain and update all assigned systems and databases. Provides regular management reports as required.
* Responsible for microbiology test method validation and equipment validation requirements in accordance with procedures.
* To manage and ensure appropriate allocation of laboratory resources and drive on-time completion of team activities.
* Accountable for software validation activities for the deployment of microbiology laboratory equipment software packages.
* Accountable for Microbiology Laboratory safety, including the timely preparation and approval of all required laboratory safety deliverables.
* Lead/manage continuous improvement initiatives within microbiology systems.
* To lead/manage microbiology laboratory related non-conformances, CAPA’s, planned deviations, change controls, OOS’s as required, ensuring corrective actions are fully implemented to address root causes etc.
* Perform other activities as and when required to support laboratory operations.
Skills & Experience
* Preferably 7+ years’ experience working in the Medical Device / Pharmaceutical Industry within a R&D/product development role.
* Experience with FDA 510k submissions and test methods for microbiological claims.
* Strong background in microbiology, significant experience, track record and knowledge within Microbiology or a Laboratory Management environment.
* A drive for excellence and high attention to detail.
* Ability to lead, motivate, develop, and influence a team.
* Competent to provide technical support and advice to other functions and franchises; serves on various teams as a functional leader.
* Strategic thinking capabilities evidenced by successful delivery of projects in a previous laboratory role.
* Strong organisational skills and the ability to manage business complexity and multiple priorities at one time.
* Ability to network internally and externally and stay engaged via industry best practices and standards.
* Good interpersonal skills and ability to form effective working relationships
Qualifications/Education:
* Degree level in a biological science discipline, preferably in microbiology.
* Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2015, FDA 21 CFR part 820) and GMP Guidelines and Regulations.
* Possess a flair for problem solving, identifying inefficiencies and implementing solutions.
* Microsoft Office skills are essential.
* Working knowledge of statistics and software packages are preferable.