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Principal Microbiologist

ORS Partners
Lower Chichester, Pennsylvania, US
Closing date
Sep 30, 2021

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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Company OverviewOur growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.People join Quotient Sciences because we are a respected member of the drug development world, specializing in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.The RoleAnalytical method development, validation, and transfer activitiesAPI/raw material sampling and testing, In-process and finished product testing, cleaning verification swabbing and testingNotebook/report review, training, technical writing activitiesImplementing, testing, using, or administrating LIMSTo comply & adhere to Good Manufacturing Practice (GMP) standardsMain tasks and responsibilities will include:Independently perform routine microbiological testing procedures in support of clinical manufacturing (API/raw materials, and drug products) according to SOPs, USP/NF, EP, and JP compendia guidelines, and standard test methodsEnvironmental Monitoring of manufacturing facility including viable surface sampling, viable air sampling, non-viable air sampling and compressed air testingAuthor semi-annual and annual reports for Environmental MonitoringEvaluate limits and industry expectations for Environmental Monitoring as needed and justify procedure, limits, etc., as requiredDocument test results in laboratory notebook, in real-time, and communicates status of test results to supervisorMaintain control of all project related samples submitted to the laboratoryWrite and review analytical reports and author technical reportsCommunicate with Clients regarding project timelines, data and ongoing studiesReview peer notebooks and analytical reportsDevelop and identify training for other personnelImplement, test, use, or administrate LIMSPerform housekeeping to assure the laboratory is continuously maintained in a safe and orderly conditionCarry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEAComply with all company and site policies and proceduresManage responsibilities and works in an efficient manner to assure accurate and timely data reportsOrder and maintain adequate supply of chemicals and general lab supplies to support microbiological testingIndependently resolve any issues with sample preparation, instrument performance, data acquisition and analysis as it applies to data integrity and accuracyAdditional Responsibilities:Remain current in profession and industry trendsMake a positive contribution as demonstrated by making suggestions for improvementLearn new skills, procedures and processes including aspects of formulation developmentIs available for other duties as requiredIs available for overtime as neededJob DemandsThe job may involve the following:Very high concentration of workStrict and tight deadlinesHaving to juggle a range of tasks/issues simultaneouslyWorking in a hazardous environment with high requirement to follow safety proceduresWorking outside normal working hoursNeeding to respond to client demandsThe CandidateRequires B.S. in Microbiology, Chemistry, Pharmacy or equivalent with at least 5 years of industrial pharmaceutical microbial laboratory experienceFull knowledge of fundamental microbiology procedures and techniques including aseptic technique, plate count procedures, and organism identification procedures is requiredCompany benefitsIn return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
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