Microbiology Specialist
6 months ago
Job Description
Responsibilities include:
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.
Qualifications
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 8 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.
Additional Information
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 62,000 staff across a network of more than 1000 independent companies in over 62 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
