Microbiologist

We are seeking a highly skilled Microbiologist to join our team at Tailstorm Health Inc. The successful candidate will be responsible for performing routine and process-based environmental and personnel monitoring in aseptic manufacturing environments.

• Performing routine- and process-based environmental and personnel monitoring in aseptic manufacturing environments.
• Performing Bioburden, Endotoxin, Total Plate Count, Coliform, Biological Indicator testing, and Plate Reading.
• Performing sterility testing of finished product.
• Ensuring ongoing stability testing of products, communicating with other team members to solve problems.
• Writing and reviewing material specifications and performing material qualifications (media and reagents), writing reports, sending emails.
• Initiating and investigating microbiology related deviations, OOS investigations, and implementing appropriate CAPAs as needed.
• Performing routine QC responsibilities such as sample coordination, lab equipment maintenance, QC document management, QC inventory control and reconciliation of sample requests/documents, as needed.
• Assisting QA in qualifying suppliers and vendors.
• Monitoring laboratory equipment for temperature, humidity, etc., and conformance to specifications.
• Able to develop methods of new products/components, author protocols and test methods, execute and troubleshoot findings.
• Assisting in the training of new hired QC staff and/or microbiologists
• Performing other duties as requested, directed, or assigned.

• Bachelor's Degree in Natural Sciences (Biology, Microbiology, Medical Technology)
• At least 1-2 years of experience working in a microbiology, chemical, analytical laboratory; working with a registered quality system in pharmaceutical production and/or manufacturing environment and/or FDA Good Manufacturing Practices and regulatory audits preferred.
• Basic knowledge on Microbiological Laboratory Techniques and equipment required
• Specialized knowledge and/or experience in method development of microbiological methods in one or more disciplines of Microbiology preferred
• Very strong Microsoft Office Suite skills (Word, Excel, Outlook, etc) and the ability to learn and operate other specific applications and software.
• Able to read, write, and speak English Fluently
• Able to travel to both of our facilities

• Microbiological Analysis of Potable and Purified water.
• Environmental Monitoring of Production area as well as Microbiology Laboratory.
• Microbiological Analysis of Raw Materials and Finished Products (Microbial Limit Test).
• Sterility Testing.
• Bacterial Endotoxin test.
• Media Preparation and Growth Promotion Test of Medias.
• Bioload of Packaging Materials.
• Bioload of Equipments and Operators by Contact Plate Technique.
• Preservative Efficacy Test.
• Disinfectant Efficacy test.
• Subculturing and Culture Dilution.
• Maintenance of Media Stock.
• Microbial Method Validations of Raw Materials and Finished Products.
• Viability of Biological Indicators and Stock Maintenance.
• Preparation of Master Standard Operating Procedures, Equipment operating procedures, Instrument operating procedures.
• Preparation of Master Test Data Sheets and Validation Protocol and Reports.
• Preparation of Environment and Water Trends.
• Handling of Out Of Specification and preparation of Corrective and Preventive Action.
• Work Allocation and Manpower Handling.
• Review of all department related SOPs and updation.
• Responsible for Change controls for microbiology.
• Responsible for handling of deviation for microbiology.
• Responsible for OOS investigation in Microbiology.
• Responsible for CAPA in Microbiology Lab.
• Checking of reports of MLT, Antibiotic Assay, Sterility, BET, water analysis, Environment monitoring etc.
• Review of Trends for water and environment.
• Review of Medial fill activities and documents and active participation in media fill.
• Sterility assurance of aseptically filled product.
• Review of Area qualification documents and gowning qualification documents for aseptic area.
• Responsible for overall responsibilities of microbiology department.