Posting ID: JP-001974623
This will be a Senior Microbiology position that would be the "team lead"/supervisor. The goal of this role is to promote to the Lab Manager within 12-24 months.
- 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
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 and Chemistry
Additional Skills & Qualifications:
Bachelors Degree in Microbiology, Biochemistry or Chemistry
Minimum 4+ Years of Microbiology Experience (environmental monitoring, sterility testing, bioburden testing, etc)
Minimum 4+ Years experience in Pharma/Med Device Laboratory
Some supervisor/lead experience, they would like to promote this role to management in 12-24 months
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
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.
Recruiter: Amy Nguyen
Phone: (714) 481-2114