QC Micro Analyst
Job details
As a QC Micro Analyst you would perform testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities. Note, this is a shift based role (12/7 - extended days) In this role a typical day might include, but is not limited to, the following:
- Entering a Laboratory Cleanroom to collect and log samples for microbial analysis
- Performing bioburden and endotoxin sample analysis in accordance with standard operating procedures (SOPs)
- Performing or supporting the sample analysis for microbial identification
- Performing environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas
- Performing acceptance testing of commercially prepared microbiological culture media
- Autoclaving microbiological media and laboratory waste as needed
- Ensuring that all work carried out is in compliance with the required regulatory standards, conforming to company policies and standard operating procedures (SOPs)
- Completing own test records on time and peer reviews data from other analysts for accuracy and completeness
- Assisting in the design and set-up of the QC microbiology laboratory and selection/ implementation and calibration of laboratory instruments
- Participating in microbiological validations as needed for drug substance, in-process controls, buffers and clean utilities qualification program
- Assisting manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed
- Participating in the transfer of methodology from other test facilities
- Maintaining laboratory reagents, media and supplies
- Conducting laboratory investigations and generating reports in response to invalid assays, Deviations, OOS/OOT
- Initiating and completing CAPAs and Change Controls in accordance with site procedures
- Writing new and updates current SOPs as needed
- Providing training to other analysts in the QC group
- Performing other duties relevant to the QC laboratory position as required.
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