Microbiologist II - Elkton - Quality

Description

Job Summary

The Microbiologist II independently works on projects as assigned in establishing and maintaining microbiology programs which include contamination control environmental monitoring bioburden testing bacterial endotoxins testing and critical utilities testing water and compressed air S/he collaborates with cross functional groups to investigate laboratory and microbiological issues and implements corrections and improvements that directly affect product safety quality operational efficiency.

• Supports microbiology/sterility assurance programs including contamination control environmental monitoring product microbiological monitoring Generates trend analysis reporting for microbiology programs Supports cleanroom certification qualification activities as assigned Conducts laboratory excursion investigations supports nonconformances CAPAs related areas of micro biology sterility assurance Authors reviews approves document revisions Supports change requests/change orders for micro biology sterility assurance initiatives Independently develops executes implements micro biological test methods in accordance applicable regulations FDA ISO AAMI etc Maintains current knowledge of micro biological testing techniques equipment Supports qualification activities IQ OQ PQ maintains laboratory equipment project initiatives Performs maintenance calibrations on laboratory equipment Performed detailed technical review approval laboratory test records protocols/reports etc Performed bio burden toxic ec enzyme Projects spent Microbiology Programs. -Cleanroom Certification Qualification Activities- Laboratory Investigation & Excursion Evaluation, Issue Resolution-Support Sterilization Assurance Initiatives
• Bachelor's degree required In a related field such as: Biology Biological Sciences Biomedical Engineering Etc Strong writing skills with proven experience authoring scientific documents Preferred BA/BS plus five years relevant work experience preferably medical device or pharmaceutical industry