SUMMARY OF RESPONSIBILITIES
The Microbiologists work in different areas : To conduct biological indicator work for sterilizer qualifications and conduct sterility testing on Alliston stabilities and imports.
Process biological indicators from sterilizer qualifications. Provide back up to other areas of the Sterility Assurance Department when needed.
The top two priorities for all Baxter Alliston employees are Safety and Quality : Safety : Support our goal to achieve a Zero Harm Environment , by ensuring the safety of yourself and your co-workers through :
Quality : Ensure the quality of our products to ensure patient safety and achieve our mission of Saving and Sustaining Lives .
This can be achieved through :
As part of the plant’s Enterprise Management System (EMS ), all employees must embrace a culture of Continuous Improvement by :
ESSENTIAL DUTIES AND RESPONSIBILITIES
D Time Spent Major Responsibilities / Activities 30% Perform sterilizer qualifications to validate the sterilization process.
Maintain records and analyze qualification data to insure quality products.
Filling and probing of units, also pouching and sealing, Volume displacements.Program the Datalogger (Digi or Validator 2000) for studies.
Perform study. Run the study and record events. Analyze study data and printout. Record pertinent information. Perform experimental equivalency, cycle developments, Initials, 24pt.
22pt., 2 year requals and 6 month vessel quals.Prepare protocol reports and write protocol section required for job. Also adding protocols in each study affected, before and after final report (Have to track the final report down and put a copy into each study affected).
Autoclaves, PRTs, MRTs, Digi calibrated Quarterly.Vessel checks done quarterly and annually. 30% Conduct sterility testing for stability and import samples, initial and fractional qualification studies and requalification’s by open and closed method filtration and / or drop tests and macerations, in accordance with SOP requirements, completing all required documentation.
10% Read and document results of appropriately incubated samples. Address all out of limits and positive test results by completing trending analysis (OOL investigation), retest procedures, gram staining, thermal death testing, microscopic analysis etc.
Review and sign off completed paperwork prior to being sent to the Documentation Centre. 5% Prepare, growth test and pH adjust a variety of media and buffer solutions, required for Sterility testing and Environmental monitoring.
Rehydrate organisms and maintain stock cultures used for growth testing. 5% Perform daily solution bio burden testing, examining total count, coliform count and spore count in accordance with SOP.
Ensure required documentation is completed, and required samples are accounted for. Conduct testing of raw materials upon request.
5% Obtain water, air and surface samples from designated sample sites within the facility on a daily, weekly, monthly and quarterly basis as part of the Environmental-
monitoring program. Conduct the required testing and incubation of these samples in accordance with specifications. 5% Perform required testing and complete documentation required for critical work request and protocols by prioritizing daily and weekly testing schedules to allow time for required tests.
5% Maintain 6S within the lab areas assigned. Provide back-up coverage to the Sterility Assurance Department when needed.
5% Maintain equipment inventories and order laboratory supplies as needed. Ensure equipment calibrations are performed in a timely manner.
Prepare and sterilize laboratory equipment to ensure its availability for use, dispose of biohazard materials appropriately, and perform monthly preventive maintenance.
Monitor incubator and refrigerator charts and thermometers daily.
Education Level Required :
Preferred : Major Subjects / Specialties Required :
Type of Experience Required :
Additional Skills / Special Training / Technical Skills Required Required :