This is a first shift, temp to permanent opportunity.
The Role
In this role, you will perform routine environmental monitoring and critical utilities (water and process gasses) sampling of the GMP manufacturing facility. The Quality Control Associate l will also support microbiological testing for GMP QC raw materials, excipients, drug substance and finished product testing for mRNA products produced at a manufacturing facility. The Quality Control Associate may perform projects as assigned.
Here's What You'll Do
- Perform routine environmental monitoring and critical utility sampling activities.
- Conduct analysis of water samples to include TOC, Conductivity, Bioburden, and Endotoxin.
- Conduct process gasses testing for Total particulates, Viable Air, Hydrocarbons and Dewpoint.
- Perform routine testing in support of manufacturing processes to include bioburden, sterility, endotoxin, culture purity and cell stock identity.
- Prepare and ship contract laboratory testing samples including those intended for microbiological identification.
- Perform general laboratory support activities including equipment maintenance and housekeeping.
- May participate in equipment and method qualifications, validations, and method transfers.
- Perform data entry utilizing good documentation practices.
- Support initiation/closure of quality system records such as environmental monitoring excursion notifications and deviations.
- Write/revise standard operating procedures.
- Additional duties as may be assigned from time to time
Here's What You'll Need (Basic Qualifications)
- BS in a relevant scientific discipline and 5 years Quality Control experience in a cGMP organization with a focus in Microbiology
- Must be experienced with Environmental testing and monitoring including gas, compressed gas, and water collection.
- Testing is performed in a clean room, not a laboratory, and may require PPE
- This position is site-based, requiring you to be onsite full-time. This position is not eligible for remote work.