Microbiologist

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 liveswhere your purpose accelerates our mission.

Summary

Perform the quality functions at the Center for Intravenous Admixtures (CIVA) as a microbiologist, supporting with the collection and processing of air (viable/non-viable) and surface samples (viable) as part of the Environmental Monitoring program. Initiation and timely completion of out of limit investigation. Support to key site projects as required and provide microbiological guidance to ensure compliance with Baxter Corporate Policies, SOPs and applicable regulatory requirements. Monitor compliance through ongoing reviews and implement continuous improvements.

This position is based out of CIVA facility with weekly travel to Baxter facility located at Alliston

Major Responsibilities / Activities

• Obtain 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.
• Ensure required documentation is completed, and required samples are accounted for.
• Perform required testing and complete documentation required for critical work request, qualification/re-qualification, and protocols by prioritizing daily and weekly testing schedules to allow time for required tests.
• Read and document results of appropriately incubated samples, addressing all microbial out of limits and positive test results, by completing trending analysis (OOL investigation) and retest procedures. Review and sign off completed paperwork prior to being routed for approval
• Track and trend environmental monitoring results and submit a monthly, quarterly and annual summary report.
• Evaluate cleanroom practices and aseptic technique
• Continuously improve CIVAs Environmental Monitoring program based on test results and risk assessment, Corporate Quality Policies and applicable regulatory standards.
• Actively participate in the Environmental Monitoring Performance Qualification (EMPQ) Risk Based Life Cycle Management (RBLCM). Process Failure Modes and Effect Analysis (PFMEA), Real Time Risk Assessment (RTRA)
• Conduct media growth promotion testing at the Alliston lab
• Rehydrate organisms and maintain stock cultures used for growth testing.
• Prepare and sterilize laboratory equipment to ensure its availability for use, dispose of biohazard materials appropriately, and maintain inventory of supplies for the Environmental monitoring.
• Monitor incubator charts and thermometers daily and report any failures and/or issues.
• Maintain the Microbiology laboratory and verifying that appropriate certifications programs is up to date.Ensure SOPs and Specifications are up to date and procedures are being followed. Review SOPs and Specifications regularly, and write new procedures when required.
• Review historical data and determine new EM alert limits
• Maintain an audit ready state in all areas. Participate in internal and external audits. Correct and resolve identified audit items.
• Work on improvement projects, validations, and other Quality duties as assigned

Qualifications.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

Competencies Required:

• Critical Thinking & Problem Solving
• Communication
• Collaboration & Teamwork
• Motivating & Developing Others
• Dealing with Ambiguity
• Customer Focus

Additional Skills / Special Training / Technical Skills Required

Required:

• 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.
• Strong technical writing skills
• Ability to work off shift, holidays and facility shut downs
• Must comply with Good Laboratory Practices

Preferred:

• Understanding of LEAN enterprise through the application of LEAN tools in a laboratory/cleanroom environment

Education and/or Experience.

Education:

Required:

• Bachelor of Science Degree

Preferred:

• Bachelor of Science Degree (Pharmacy or Microbiology)
• Knowledge of Good Manufacturing Practice
• Knowledge of USP 797

Experience:

Required:

• Previous experience working in a Quality function
• Experience in Aseptic Technique and Microbiological Methods
• Microbiological testing lab experience in the pharmaceutical industry
• Proficiency in Word & Excel

Preferred:

• Experience in cleanroom environment
• Experience in a pharmaceutical manufacturing environment
• Knowledge of GMP, ISO standards, and regulatory requirements

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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