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Lab Quality Specialist
2 weeks ago
Job Overview
PSC Biotech is a leading consultancy firm providing cloud-based software solutions for quality management and regulatory inspections.
The QC Microbiology Analyst role plays a critical part in ensuring compliant design, construction, qualification, and operation of the new biotech drug substance facility.
Key Responsibilities- Designing efficient lab testing flows based on lean principles
- Qualifying the microbiology QC lab and transferring microbiological analytical methods
- Developing high-performing teams that exceed client expectations regarding quality and meeting timelines
Day-to-Day Tasks
The candidate will perform routine microbiological techniques including environmental monitoring, WFI testing, growth promotion testing, in-process and final product testing (bioburden, kinetic turbidimetric, MCS endotoxin testing) in GMP compliance.
- Completing documentation timely and being familiar with LIMS
- Training in rapid microbiology techniques
- Following current analytical practices per pharmacopoeias, regulations, and standards
- Updating SOPs and writing protocols as needed
Collaborative Environment
The role involves working with a high-performing, cross-functional team from the biotech industry, building the future of biotech through a quality culture focused on delivering right first time to patients.
Opportunities for development within microbiology and chemistry labs are available, including continuous development and knowledge building.