Microbiology Specialist- 12 Month Fixed Term Contract

About the Company

My client is a world leader in food, environment and pharmaceutical product testing. They are also one of the market leaders in testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing.

About the Position
This role offers you the opportunity to work in a cross functional team to support the Microbiology Quality Control testing function, ensuring compliance with cGMP.
The role holds senior responsibilities within the Microbiology Laboratory including (but not limited to) organising, scheduling and coordinating routine day-to-day laboratory operations and Microbiology validation activities.
Providing technical oversight and supervising laboratory testing/ review activities. You will provide technical expertise, troubleshooting, training and support to laboratory technicians and ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to customers

Key Responsibilities

• Operate as part of self-directed work team in allocating testing and assigning tasks based on priorities, including daily, weekly, monthly and quarterly tasks. Perform tasks with a high degree of precision and accuracy and ensure others do likewise.

• Liaise effectively with external groups such as Manufacturing, Tech Ops, CQV, Plant Engineering and QA to ensure laboratory support is available as required and testing timelines are met.

• Ensure adherence to lab testing schedules, applying Lean Lab methodology.

• Ensures testing/data review are supported and that results are available within lead times to laboratory customers. Anticipated delays should be escalated, with proposed solutions for resolution.

• Ensures projects are supported and completed as per project timelines. Anticipated delays should be escalated, with proposed solutions for resolution.

• Author/provide leadership in the Laboratory/Contamination investigations using own initiative and with minimum supervision.

• Coach and mentor the Laboratory Team.

• Work as directed by according to Company safety policies, cGMP and cGLP.

• Facilitate and drive effective communication to ensure success.

• Ensure the Lab Tier/handovers are facilitated, and attendance expectations are met.

• Provide support with audit/inspection requirements to ensure department compliance/readiness.

• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.

• Development and execution of Microbiology test methods, Method Validation and Method Qualification.

• Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.

• Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.

• Ensure that the customer gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards and GMP compliance.

• A degree in Microbiology or a related discipline is required with a minimum of 6 years’ within a pharmaceutical regulatory environment.

Experience / Skills

• At least 6 years’ experience in an GMP environment, preferably within QC microbiology department.

• Strong knowledge in microbiology related lab test method methods e.g. Environmental Monitoring, Microbial Identifications, Bioburden testing, Endotoxin testing, Biological Indicator Testing, Absence of Contamination Testing (BacT), Growth Promotion/Sterility Testing.

• Experience with New Product Introduction and Microbiology Method Validation experience.

• Deep understanding of data integrity and the importance of adopting this guidance when reporting results / everyday work.

• Is proficient in the use of numerous laboratory instruments, software packages and other analytical techniques.

• Is proficient in problem solving and may have expertise in troubleshooting laboratory equipment.

• Thorough understanding of requirements for working in a GMP environment.

• Ability to quickly learn new processes.

• Ability to communicate clearly and to form strong working relationships with colleagues.

• Ability to work on own initiative and be capable of developing solutions to problems as part of a team.

• Willing to operate in a flexible manner and be able to switch priorities at short notice.

• Good team player, organised, accurate, have strong documentation skills.

• Passionate about quality and customer service.

• Good communication skills both internally and externally and avoids making mistakes that will hinder the understanding of his/her written and verbal exchanges.