Microbiologist - Midnight shift (Sunday to Thursday 23:00-7:30)

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.

Summary

We are looking for a dedicated Microbiologist to join our world-class team on our Midnight shift (Sunday to Thursday 23:00-7:30). This unique opportunity allows you to contribute to a leading healthcare company that is committed to saving and sustaining lives, while working in a dynamic and supportive environment.

The Microbiologist supports activities in the Sterility Assurance department to ensure timely completion of tasks and compliance with applicable requirements. You will act as a delegate to the Sterility Assurance Supervisor in all matters as required and in their absence. The role involves performing daily tasks in the respective areas and providing backup to other areas of the Sterility Assurance Department when needed.

Essential Duties and Responsibilities

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 by following all safety procedures.

• Understand potential hazards in your area
• Wear appropriate PPE
• Report all incidents, near-misses, and concerns
• Embrace 6S principles

Quality: Ensure the quality of our products to guarantee patient safety and achieve our mission of “Saving and Sustaining Lives.”

• Follow Good Manufacturing Practices (GMP)
• Adhere to all quality procedures
• Complete training on time
• Do it Right the First Time
• Report any quality concerns immediately

As part of the plant’s Enterprise Management System (EMS), all employees must embrace a culture of Continuous Improvement.

• Participate in improvement activities
• Identify and implement continuous improvement ideas
• Participate in Tier meetings
• Recognize your peers
• Embrace 6S
• Identify and implement VIPs (Value Improvement Projects)
• Embrace continuous learning
• Apply Leader Standard Work
• Employ Root Cause Analysis tools to identify and prevent problems from recurring and drive measurable results
• 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 before sending it 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.
• Perform sterility testing for stability and import samples. This includes initial and fractional qualification studies, as well as requalifications. The testing will be done using open and closed method filtration, drop tests, and macerations. All testing will be conducted in accordance with SOP requirements, and all required documentation will be completed.
• Collect and organize production samples and check for discrepancies against sterilized sample records. Maintain equipment and area for testing to ensure endotoxin-free product and perform bacterial endotoxin testing per specification.
• Perform required testing and complete documentation for critical work requests 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.
• 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.
• Maintain 6S within the lab areas assigned. Provide backup coverage to the Sterility Assurance Department when needed.

Qualifications

• University Degree or equivalent experience is required, such as a B.Sc designation or other academic qualifications.

- Proven experience in 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
• Environmental monitoring experience
• Working experience in a regulated microbiology lab and understanding of industry best laboratory practices and techniques
• Previous experience with Laboratory Information Management System (LIMS) preferred
• Validation experience within Life Sciences manufacturing environment
• Writing and completing validation protocols
• CAPA investigation experience
• QA experience in a pharmaceutical manufacturing environment
• Microbiological testing lab experience in the pharmaceutical industry
• Knowledge of GMP, ISO standards, and regulatory/corporate requirements
• 4-5 years of experience required; 5+ years of successful progressively responsible experience preferred
• Ability to work independently and as part of a team, with self-motivation, adaptability, and a positive attitude
• Time management and prioritization skills
• Strong analytical and problem-solving skills and critical thinking abilities
• Strong process and project management capabilities
• Excellent oral and written communication skills demonstrated through presentations/seminars and oversight of projects
• Strong technical writing skills
• Must be able 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 and ability to work with all levels of the organization
• Strong ability to balance multiple priorities with excellent time management skills
• Diligent with the ability to work under pressure
• Uncompromising dedication to quality
• Must align 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 preferred

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.

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