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Scientist II, QC Microbiology Specialist
2 months ago
The Renaissance LLC is seeking a highly skilled Scientist II, QC Microbiology to join our team. As a key member of our Quality Control Microbiology Laboratory, you will be responsible for testing and reporting cGMP test results, providing training and support to less experienced laboratory staff, and ensuring compliance with current GMP requirements and company safety policies.
Key Responsibilities- Perform microbiological analysis on received test samples, including raw materials, bulk, final product, stability, and water, as per USP, in-house, or customer methods.
- Evaluate, record, and report data under minimal supervision.
- Perform environmental monitoring, as required, and evaluate, record, and report data.
- Conduct quality control testing of media, reagents, and identification materials.
- Maintain adequate inventory of media and materials required for testing.
- Initiate proper documentation upon discovery of deviations and out-of-specification results, complete Trackwise write-ups for deviations and out-of-specification results.
- Perform special projects as assigned, including testing, compiling, and trending of data and report generation.
- Perform data entry for tracking and generate trend analysis reports for the EM program.
- Revise SOPs, forms, protocols, and other controlled documents.
- Perform micro identifications using manual testing and automated systems.
- Maintain lab stock cultures for evaluative testing and make dilutions of stock cultures as required by procedure, protocol, or USP requirements.
- Maintain intradepartmental communication to support company goals.
- Review laboratory logbooks to ensure compliance with good documentation practices.
- Release manufacturing areas after recovery using the ASCN in Trackwise.
- Write Trackwise notifications and deviations and complete CAPAs.
- Create and complete Trackwise change controls.
- Write and revise SOPs, forms, risk assessments, and other controlled documents.
- Interact with Operations staff to facilitate data and documentation corrections.
- Interact routinely with departments such as Production, Quality Assurance, and Regulatory Affairs.
- Create purchase orders as needed.
- Bachelor's degree in biology, health science, or microbiology.
- 2-5 years of experience in cGMP micro expertise.
Yearly Salary
