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Microbiologist

Req #: 170009JW_en
Location: Alliston, ON CA
Job Category: Quality
Date Posted: 11/7/2017 1:41:30 PM
Baxter International
The Microbiologists work in different areas: Perform daily solution bio burden, particulate matter and pyrogen testing.  Collect and process viable and non-viable air, water, solution and surface samples as part of the Environmental monitoring program. 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 Microbiologists work in different areas: Perform daily solution bio burden, particulate matter and pyrogen testing.  Collect and process viable and non-viable air, water, solution and surface samples as part of the Environmental monitoring program. 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:
  •  following all safety procedures
  •  understanding potential hazards in your area
  •  wearing appropriate PPE
  •  reporting all incidents / near-misses / concerns
  •  embracing 6s
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:
The Microbiologists work in different areas: Perform daily solution bio burden, particulate matter and pyrogen testing.  Collect and process viable and non-viable air, water, solution and surface samples as part of the Environmental monitoring program. 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:
  •  following all safety procedures
  •  understanding potential hazards in your area
  •  wearing appropriate PPE
  •  reporting all incidents / near-misses / concerns
  •  embracing 6s
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:
  • following Good Manufacturing Practices (GMP)
  • adhering to all quality procedures
  • completing training on-time
  • Doing it Right the First Time, and
  • reporting any quality concerns immediately.
 
As part of the plant’s Enterprise Management System (EMS), all employees must embrace a culture of Continuous Improvement by:
  • participating in improvement activities
  • identifying and implementing continuous improvement ideas
  • participating in Tier meetings
  • recognizing your peers, and
  • embracing 6s.
  • identifying and implementing VIP’s (Value Improvement Project)
  • embrace continuous learning
  • utilize Leader Standard Work
  • utilize Root Cause Analysis tools to identify and prevent problems from recurring and drive measurable results.
ESSENTIAL DUTIES AND RESPONSIBILITIES
 
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.  

 
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.
 
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.
 
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.
 
Collect and organize production samples and check for discrepancies against sterilized sample record.  Maintain equipment and area for testing to ensure endotoxin free product and perform bacterial endotoxin testing per specification.
 
Perform sterilizer qualifications to validate the sterilization process.  Maintain records and analyze qualification data to insure quality products. Prepare for study. This involves ordering of bags from Kiefel without ports, adding a probe holder and then adding ports in Heat Seal. Filling and probing of units, also pouching and sealing, Volume displacements.
 
Drive continuous improvement of environmental controls by performing real time risk assessments in classified areas. Work on improvement projects and validations as assigned.
Maintain 6S within the lab areas assigned.  Provide back-up coverage to the Sterility Assurance Department when needed.
 
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 maintenanceMonitor incubator and refrigerator charts and thermometers daily.
 

Education/Experience

Education Level
Required:
  • University Degree, B.Sc. designation
Major Subjects / Specialties
Required:
  • Microbiology
  • Quality Assurance
Type of Experience
Required:
  • Experience in a manufacturing environment
  • Proficiency in Word & Excel
  • Previous experience working in a Quality function
  • Knowledge of Aseptic Technique and Microbiological Methods
Preferred:
  • Previous experience with Laboratory Information Management System (LIMS)
  • Microbiological testing lab experience in the pharmaceutical industry
  • Knowledge of GMP, ISO standards, and regulatory/corporate requirements
Years of Experience
Required:
  •  1 - 2 years
Preferred:
  • 2 + years
 
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