QC Microbiologist specialist

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

Full-time