Job Description
Job Description
QC Microbiologist specialist is responsible for review of microbiological method validation, microbiological testing of raw materials, in-process samples, finished product. The incumbent is also responsible for Autoclave Validation/revalidations and work with R&D Staff on New product sterility and Endotoxin LAL validation.
Reporting to: Director of Quality Assurance and Regulatory affairs
Qualifications:
Bachelor of Science in Microbiology from a recognized Institution /University
Experience:
- One year experience in the pharmaceutical industry with microbiological testing such as sterility/bioburden, new product validation, raw material /finished product testing, LAL testing and validation, microbial identification, gram staining, purified water testing as per USP (membrane filtration, endotoxin and TOC), bacteriostasis and growth industry
- Experience in environmental monitoring of cleanroom, environmental excursion investigations, DET, and the evaluation of aseptic media fills
- Experience with QC test scheduling
- Experience with GMP, GLP regulations and ISO standards
- Experience with Microsoft suite
- Excellent communication skills
Job description
- Perform bioburden, endotoxin and TOC testing of Water including water for injection (WFI) per USP method.
- Assist with review and approval of Standard Operating Procedures
- Train and review the work of microbiological technicians
- Review environmental class 5 to 8 cleanroom areas, maintain data on environmental monitoring of the facility.
- Track and trend environmental monitoring and working with Quality Assurance Management on continuous improvement activities of facilities contamination control.
- Assist with the development and validation of Microbiological methods
- Review and approval of microbiological validation record
- Perform internal audit per schedule or assist Quality Assurance with external audits.
- Other duties may be assigned