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Quality Control Microbiologist I - Day

Req # JR - 172918 Location Alliston, Ontario, Canada Job Category Microbiology Date posted 06/02/2025
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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

Quality Control Microbiologist I - Day

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This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Your Role at Baxter

This is where my hands make life-sustaining products 

You are driven by the knowledge that the products you help make saves and sustain lives. You can move quickly, address questions, and encourage teammates, all while getting quality products out on time. You are calm, positive, and a key part of a fast-paced environment that emphasizes camaraderie and teamwork. As a Quality Control Microbiologist, you are happiest when you are moving, and we will not disappoint!  

Baxter is known for its speed and high-quality product. Our manufacturing operations are around-the-clock to meet the needs of our customers. Our high-caliber talent works through the challenges at hand while pushing toward meeting client order needs. We are currently looking for a Microbiologist to work a permanent, full-time position on our Day shift (Monday to Friday 7:30h-16:00h EST), at our Alliston facility!

Your team  

Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day.  

Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce.  

The following are dress/gowning requirements: safety glasses, safety shoes, ear plugs, jumpsuit, hood, hairnet, beard cover, gloves, isolation mask and boots (additional PPE required when cleaning) 

  • Constant or intermittent exposure to elevated levels of noise 

  • Involves working around equipment, machinery, and belts 

What You'll be Doing:

The Microbiologists perform daily solution bioburden, subvisible particulate matter and endotoxin testing. They collect and process viable and non-viable air and surface samples as part of the Environmental Monitoring program. They also sample and test the critical systems like compressed air and water. They are responsible for processing the biological indicators associated with sterilizer qualifications as well. They also provide back up to the Supervisors and QC specialist to aide with investigations, trending and data analysis for APQRs, Validation Maintenance, etc

  • 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, incubation and plate reading of these samples in accordance with specifications.

  • Perform daily solution bioburden testing for total count and spore count in accordance with approved procedures ensuring required documentation is complete and all results are read in a timely manner. Conduct testing of raw materials as required.

  • Perform processing of biological indicators to support sterilizer qualifications

  • Perform daily endotoxin and subvisible particulate testing of finished goods as per approved procedures and specifications.

  • Perform required testing and complete documentation required for critical work requests and emergency response incidents (i.e. differential pressure alarm) to support timely start up of production following the work and/or incident

  • 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.

  • Improve the effectiveness of all team members by providing documented training, mentoring employees during feedback reviews, and daily activities to improve skills, providing recognition for good performance.

  • Prepare and/or perform growth promotion testing on prepared or purchased media

What You'll Bring:

  • College diploma or University Degree in a related field (Microbiology)

  • Microbiology

  • Quality Assurance

  • Experience in a manufacturing environment • Proficiency in Word & Excel

  • Previous experience working in a Quality function

  • Knowledge of Aseptic Technique and Microbiological Methods

  • 0- 2 years

  • Strong analytical and problem solving skills and critical thinking abilities

  • Strong communication skills, ability to work with all levels of the organization.

  • Strong ability to balance multiple priorities with excellent time management skills.

  • Detail oriented with the ability to work under pressure.

  • Uncompromising dedication to quality.

  • Ability to work off shift, holidays and plant shut downs on a rotating basis.

  • Coverage for production overtime Saturdays on a rotating basis is mandatory

  • Must comply with Good Laboratory Practices

  • When performing Sterilizer Quals: the work is conducted in extreme environmental conditions (temperature, humidity, wet, moving trucks, loud, hot pipes)

#LI-AR1

#IND-CA

Summary

The Microbiologist supports activities in the Sterility Assurance department to ensure timely completion of tasks and compliance with applicable requirements. Acts as the delegate to the Sterility Assurance Supervisor in all matters as required and in their absence. Perform daily tasks in the respective areas as required and provides 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.

Roles and Responsibilities

  • 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”. 
  • Following Good Manufacturing Practices (GMP)
  • Adhering to all quality procedures - Completing training on-time - Doing it Right the First Time
  • Reporting any quality concerns immediately.
  • Aspart 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

  • Review daily results and paperwork from Environmental, Particulate Matter and Pyrogen labs. Support review of paperwork from Sterilizer Quals as needed.
  • 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. 
  • Compile data required for monthly, quarterly and annual trending.
  • Coordinate required testing and compile/review resulting data for CWRs and validations.
  • 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. 
  • Compile data required for monthly, quarterly and annual trending
  • 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.  Assist in completion of OOL and CAPA investigations, and resolution of audit observations. Participate in and support plant projects and validations as required.
  • Drive continuous improvement of environmental controls by performing real time risk assessments in classified areas. Work on improvement projects and validations as assigned. 
  • 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 maintenance. Monitor incubator and refrigerator charts and thermometers daily.
  • Support day shifts from Tuesday to Saturday
  • Maintain 6S within the lab areas assigned.
  • Provide back-up coverage to the Sterility Assurance Department when needed.

Qualifications

  • University Degree, B.Sc designation, or equivalent academic qualifications and work experience required.
  • Major Subjects / Specialties - 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
  • Environmental monitoring
  • Working experience in a regulated microbiology lab and understanding of industry best laboratory practices, techniques.
  • Previous experience with Laboratory Information Management System (LIMS)
  • Validation experience within Life Sciences manufacturing environment
  • Writing and executing validation protocols.
  • CAPA investigation
  • QA experience in a pharma manufacturing environment
  • Microbiological testing lab experience in the pharmaceutical industry
  • Knowledge of GMP, ISO standards, and regulatory/corporate requirements
  • 4-5 years of experience preferred
  • 5+ of successful progressively responsible experience.

  • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
  • Time management / prioritization.
  • Strong analytical and problem solving skills and critical thinking abilities
  • Strong process and project management capabilities.
  • Excellent oral and written communication skills that have been demonstrated through presentations/seminars, oversight of projects, etc.
  • Strong technical writing skills.
  • Must be required to work a schedule outside business hours and/or flexible shifts.
  • Intermediate level of proficiency with MS Office and Laboratory information management system(LIMS)
  • Experience with continuous improvement methodologies, LEAN, 6S, Kaizen, Six Sigma
  • Strong communication skills, ability to work with all levels of the organization.
  • Strong ability to balance multiple priorities with excellent time management skills.
  • Detail oriented with the ability to work under pressure.
  • Uncompromising dedication to quality.
  • Must comply with Good Laboratory Practices
  • Understanding of Sterility Assurance principles relating to moist heat terminal sterilization. Understanding of EMS through the application of LEAN tools in a laboratory environment.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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Alliston, ON L9R1W7
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Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

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