Microbiologist I.US-PBF.427

4 days left

Employer
Integra LifeSciences
Location
Plainsboro, New Jersey, US
Salary
Competitive
Posted
Jun 10, 2021
Closes
Jun 17, 2021
Ref
2241375548
Discipline
Other
Employment Type
Full time
Salary Type
Salary
Overview:
The Microbiologist I will provide to the QC Microbiology Laboratory as pertaining to the respective responsibilities. Performs functions such a executing laboratory testing for in-process and finished good products, water, stability studies, and validation studies as well as performs environmental monitoring. This position is responsible for operating in compliance with all applicable procedures and policies.ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, anindividual must be able to perform each essential duty satisfactory.Ensure compliance with all company polices and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive.Perform and document in-house microbiological testing on all in-process and finished products to comply wih acceptance requirements.Perform LAL, water analysis, growth promotion, gram staining, identification of microorganisms and other microbiological testing.Perform and document environmental monitoring in compliance with Standard Operating Procedures.Report any equipment and testing deviations to the Supervisor.Submit samples for shipment to third party labs when necessary.Maintain GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned.Assist with proper execution of laboratory Alert/Action (AA) and Out-of-Specification (OOS) investigations.Interact and coordinateactivities with otherdepartments and external vendors to support and meet the facility goals and objectives, especially related to environmental monitoring.Assist management in updating Standard Operating Procedures (SOPs).Perform data entry and assist with trend reporting as needed.Train team members in Microbiology department.Provide gowning training andqualification to operators, cleaning and other essential staff.Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures.Perform other relatedduties as required.

Qualifications:
Bachelor's degree, in Microbiology or Biology preferred0-3 years of relevant GMP/GLP laboratoryexperience in regulated industry preferredCapable of effective written and verbal communicationMust be able to work independently with minimal supervisionKnowledge of MS Office Suite

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