Elkton, Maryland
Sr.Microbiologist Job Opening in Elkton, Maryland - Job Summary:
The Senior Microbiologist is responsible for overseeing daily operations in the microbiology laboratory. Responsibilities include performing testing to support production, product release and on-going monitoring in accordance with SOPs and regulatory requirements. S/he is responsible for identifying microbial risks with manufacturing and the appropriate level of microbial testing and/or control. May be responsible for up to 4 direct reports.
Job Details:
Develop, revise and review SOPs, protocols and reports.
Apply cGLP, cGMP, AAMI, ISO, FDA, USP guidelines to microbiological test methods development.
Maintains a safe and compliant work environment by following internal and external standards, procedures and regulations.
Operate and maintain laboratory equipment, perform equipment troubleshooting and maintenance, recognize errors, identify root causes, apply process improvement; maintain excellent working knowledge of laboratory equipment
Coordinate activities associated with qualification and monitoring of cleanrooms and clean zones and utilities
Develop and provide training to associates on Cleanroom behavior.
Perform routine assays as required to support workload such as: bioburden, bacterial endotoxin testing, water testing, environmental monitoring (air, surface and gases), microbial isolation and characterization
Review and approve test results and reports. Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures
Interact with New Product Development and Operations Engineering teams creating and implementing plans for evaluation and testing related to microbiology/clean rooms for new/ modified products and processes
Maintains laboratory inventory and orders supplies
Train associate on test methods
Lead or participate in auditing contract laboratories and sterilizers
Gather metrics for use in continuous improvement of areas of responsibility
Performs other job-related duties assigned
Position Requirements:
Knowledge, Skills and Abilities (KSAs)
Significant knowledge and demonstrated experience in performing a variety of microbiological test methods (Bioburden, bacterial endotoxin, water testing, environmental monitoring, microbial isolation and characterization)
Strong organization skills and ability to multitask.
In depth knowledge of quality standards (ISO, FDA, GMPs, GLPs) and microbiological standard related to area of expertise
Knowledge of requirements for controlled manufacturing areas (ISO 14644) including requirements for commissioning, risk assessment and certification of clean rooms.
Working knowledge of Good Laboratory and Good Manufacturing practices.
Experience in working relationships with contract laboratories
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Ability to clearly communicate information via verbal presentations and in writing.
Basic knowledge of ethylene oxide, gamma, and dry heat sterilization methods preferred.
Basic knowledge of product particulate testing a plus.
Working knowledge of Microsoft office applications including Word, Excel, PowerPoint, Outlook and MS Project.
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Background Experiences
Bachelor degree in Biology, Microbiology, or related Science.
5+ years laboratory experience in a regulated environment
Job Type: Full-time
Required education:
Bachelor's
Required experience:
Bioburden Testing: 2 years
FDA Reguated: 3 years
laboratory: 5 years
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