Overview
Team Lead - Laboratory Services is responsible for the daily technical operation of the microbiology laboratory, supervising a team of microbiology staff, overseeing the laboratory testing schedule and ensuring all microbiological testing, processes, methods, and validation exercises conform to internal procedures, reflect applicable regulations/guidelines and meet industry best practice.
Responsibilities
* Working within a controlled ISO13485 laboratory quality system and in accordance with GLP/GMP compliant procedures.
* Supervise a team of 3-6 microbiology staff.
* Ensure microbiology lab staff are trained and proficient at their assigned tasks and follow established standard procedures for the tasks they are performing.
* Conduct General Laboratory Compliance Awareness training as part of new starter inductions; ensure lab compliance with applicable cGMP regulations and SOPs.
* Takes responsibility for the daily technical operation of the microbiology laboratory.
* Oversees the laboratory testing schedule and ensures all microbiological testing, processes, methods, and validation exercises conform to internal procedures, reflect applicable regulations/guidelines and meet industry best practice.
* Responsible for prioritisation of tasks to ensure deadlines are met in accordance with testing schedules.
* Represents the Microbiology Lab as a functional lead on various teams.
* Deputize in the absence of a laboratory manager; represents the microbiology laboratory during internal and external audits.
* Troubleshoots issues as they occur in the microbiology laboratory and manages deficiencies, OOSs, non-conformances and failures with respect to equipment, procedure, processes and test methods within the laboratory.
* Ensures all laboratory instrumentation and equipment are appropriately calibrated in accordance with regulatory requirements and calibration schedules.
* Ensures microbiology equipment is fully qualified (IQ/OQ/PQ) to expected standards; supports software validation activities as and when required.
* Performs detailed laboratory investigations to determine the root cause for atypical and out of specification results, applies corrective and preventive actions and concise report investigations.
* Writes COSHH and risk assessments for laboratory procedures.
* Position may involve minimal travel, between 1-5 days per year.
Qualifications/Education
* Degree qualified, ideally in Microbiology, Biology or a similar related discipline.
* Knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, FDA 21 CFR part 820) and GMP Guidelines and Regulations is desirable.
* Good working knowledge of Microsoft Office, specifically Word and Excel.
Working Conditions
* This role may be based in Deeside with an onsite working structure.
* Laboratory/Office Environment.
* Working in a laboratory environment with exposure to biological agents, chemicals and reagents.
Special Factors
* Exposure to biological agents (Hazard Group 1 and 2).
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