Job Title: QC Microbiology Analyst
The QC Microbiology Analyst role is a critically important activity to ensure efficient and effective compliant, qualification, and operation of the new strategic Drug Substance facility.
* This tremendous opportunity will be responsible for qualifying the Microbiology Quality Control lab and the verification of Microbiological analytical methods including but not limited to cutting edge Rapid Microbiological Methods.
* The candidate will provide support to other analysts within the lab area, including training and guidance on their area of expertise.
* The full QC analytical scope will incorporate micro, raw materials, stability, and in-process. Innovation and advanced analytical methods (rapid ID techniques, paperless lab, etc.) will allow the candidate to challenge current thinking in designing for the future.
Role Functions:
* Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI sampling & testing, growth promotion testing, TOC & Conductivity testing, in-process product testing, final product testing such as bioburden and both Kinetic turbidimetric and MCS rapid endotoxin testing in compliance with GMP requirements.
* Support the laboratory testing schedule to achieve an efficient QC system.
* Receive and manage samples that come into the lab for testing.
* Solution preparation, cleaning, routine equipment maintenance and system set-up.
* Maintain good housekeeping and GLP within the laboratory.
* Calibrate and maintain all designated laboratory instruments.
Requirements:
* 1-3 years industry experience with significant knowledge and experience working in a Microbiology Laboratory.
* Experienced in testing as per the pharmacopoeias.
* Working knowledge of QC Systems (eLogs, Electronic Lab Notebook, LIMS etc.).
Skills:
* Ability to respond to changing priorities.
* Strong organisational skills.
* Good verbal and written communication skills.
* Excellent troubleshooting and problem-solving skills.
* Ability to think logically and be proactive.
About PSC Biotech:
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.
We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.