QC EM Microbiology Analyst
Raleigh Metro Area, NC
Performs testing and associated tasks without errors per applicable SOPs and protocols.
Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
Participates in lean lab operation, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs Performs bioburden and endotoxin testing on in process and final products
Participates in cross-training to support staff availability within QC department
Performs shiftwork as necessary to support manufacturing operations. Responsible for aseptically sampling water, clean steam, environmental monitoring, and compressed gases per established sampling plans and protocols.
Responsible for performing microbiological testing of water, clean steam, environmental monitoring, and compressed gases per established testing procedures and protocols.
Responsible for performing Gram staining and microbiological identification of environmental monitoring samples
Documentation of testing activities per cGMP requirements.
Responsible for the review of laboratory data
Authors Invalid and Out of Specification (OOS) laboratory investigations
Maintain inventory of all supplies and consumables for the laboratory.
Flexible schedule and available to work weekends and overtime.
One-year experience preferred in:
Pharmaceutical Environmental Monitoring and Utility Monitoring programs
Performing bioburden, Gram staining, microbial identification, and endotoxin testing for facility water as required
Previous experience of sampling compressed gasses preferred
Proficient in the use of Microsoft Word, Excel, and Laboratory information management systems preferred.
Bachelor s degree in Microbiological science or equivalent life science preferred.