Job ID: 2024-3594 Type: Regular Full-Time # of Openings: 1 Category: Quality Control Cambrex - Charles City
Overview
Reporting to the Manager, QC, the microbiologist is responsible for independently testing finished good API samples, water samples, and environmental monitoring samples for USP <61>, <62>, and <85>. The microbiologist will also maintain to microbiology laboratory, including cleanliness and maintain supplies to perform microbiological testing.
Responsibilities
Provide microbiology laboratory testing support for the site.
Follow all OSHA and company safety rules and practices
Data review
Data entry
Perform chemical testing using analytical instrumentation including TOC, conductivity meter, and endotoxin reader.
Perform testing per USP <61>, USP <62>, and USP <85> for finished good APIs, water, and environmental monitoring samples
Write and execute microbial methods and validation protocols.
Adhering to SOPs and regulatory systems as they relate to laboratory testing operations; e.g. cGMP compliance and training
Communication with supervisors about work status and problems
Independently track reagent and media inventories
Perform aseptic repackaging of materials as needed
Receive and document sample entry into the QC system
All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
Qualifications
High school education required, an AS/AA or BS/BA is preferred
Minimum of 3 years of microbial testing experience. NLT 5 years of microbial testing experience is preferred.
