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. Your key duties and 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. • Ensures microbiology lab staff are trained and proficient at their assigned tasks and follow established standard procedures for the tasks they are performing. • Conducts General Laboratory Compliance Awareness training as part of new starter inductions; ensures lab compliance with applicable cGMP regulations and SOP’s. • 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. • To troubleshoot issues as they occur in the microbiology laboratory and manage deficiencies, OOS’s, non-conformances and failures with respect to equipment, procedure, processes and test methods within the laboratory. • Ensure 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. • Perform detailed laboratory investigations to determine the root cause for atypical and out of specification results, apply corrective and preventive actions and concise report investigations. • Write COSHH and risk assessments for laboratory procedures. Skills & Experience: • 5 years of Microbiology Laboratory work experience responsibilities. • Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (preferable ISO13485:2016, ISO9001:2015, FDA 21 CFR part 820 or equivalent), GMP and GDP. • Working knowledge and experience of microbiology related pharmacopeial/ISO standards. • Experience of supervising staff in a laboratory setting. • Background in microbiology; experience, track record and knowledge within microbiology or a laboratory environment. • Demonstrated excellent analytical and problem-solving skills and ability to interpret data from a variety of sources. • Excellent SOP, investigation, protocol, and technical report writing skills. • Microsoft Office skills are essential. • Ability to work effectively and communicate in cross-functional teams, building co-operative working relationships. • Highly motivated, possessing excellent personal attributes as well as being a flexible team member willing to take on a wide variety of tasks. 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. Travel Requirements: • Position may involve minimal travel, between 1-5 days per year. Working Conditions: • This role may be based in the 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).