Senior Microbiologist

Description:
This will be a Microbiology position that would be the "team lead"/supervisor after training.
Responsible for Environmental monitoring (total air particulate, viable air and surfaces) of the plant controlled work zones.
Conduct required microbiological tests and interpret results to ensure quality products for release or to place product on hold; such tests include:
Performs sterility testing of finished product solution samples.
Determines the bioburden level of incoming raw materials, components, and in-process solutions.
Identifies genus and species of isolates recovered from critical areas and from in-process solution samples.
Responsible for cultures and biological indicator solutions used for plant validation and product development studies.
Performs bacterial endotoxin testing of raw materials and solutions.
Collects and tests samples as required for bioburden, bacterial endotoxins and/or particulate matter.
Reviews all tests results and determines acceptability or initiate and conduct further investigation - including additional testing, root cause analysis, conclusions summarized in written records
Accountable to assess, develop, write and implement protocols as needed for improved testing and quality of product including:
New product validation protocols, out of specifications limits
Ensure the complete and accurate documentation and reporting for all microbiological tests.
Participates in all third party audits as subject matter expert
Accountable to manage CAPA (corrective action, preventative action) and lead projects related to microbiology on a global basis if applicable
Skills:
microbiology, aseptic, sampling, lab*, "Environmental Monitoring", Micro, Laboratory, Pharmaceutical, Medical Device, Bioburden, Sterility Testing, Microbiological, ISO, GMP, Quality Manager, Analytical Testing, GLP, Sterile
Top Skills Details:
microbiology, aseptic, sampling, lab*, "Environmental Monitoring"
Additional Skills & Qualifications:
Bachelors Degree in Microbiology, Biochemistry or Chemistry
Minimum 3+ Years of Microbiology Experience (environmental monitoring, sterility testing, bioburden testing, etc)
Minimum 3+ Years experience in an ISO regulated environment and gowning
Some supervisor/lead experience, they would like to promote this role to management in 12-24 months
Experience Level:
Expert Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.