Job Position: QC Microbiology Specialist
The role involves working in a Bulk Drug Facility, supporting microbiological testing including Environmental Monitoring, Water, Gas, Bioburden and Endotoxin analysis.
Key Responsibilities:
* Conduct microbiological testing for environmental monitoring, water sampling, bioburden, endotoxin, TOC with technical support for method validation.
* Maintain high standards of cGMP, GLP during testing.
* Represent the Microbiology department in internal and external audits as needed.
* Perform technical review of laboratory data, validation protocols and reports.
* Ensure all equipment is calibrated and operational.
* Maintain a safe and clean laboratory environment.
* Investigate out-of-specification results using structured problem-solving and root cause analysis tools with the Microbiology Laboratory Supervisor.
Requirements:
* At least 1 year's experience in a cGMP Quality environment.
* Experience in sterile/non-sterile pharmaceutical/bio-pharmaceutical product testing.
* Familiarity with current GMP regulations and industry standards.
* Degree in Microbiology or related field.