Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
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. Prepareandsterilize laboratory equipmenttoensure its availabilityfor use, dispose ofbiohazard materials appropriately,and perform monthly preventivemaintenance. Monitorincubatorandrefrigerator chartsandthermometers daily.
* University Degree, B.Sc. designation
*Major Subjects / Specialties*
* Quality Assurance
*Type of Experience*
* Experience in a manufacturing environment
* Proficiency in Word & Excel
* Previous experience working in a Quality function
* Knowledge of Aseptic Technique and Microbiological Methods
* Previous experience with Laboratory Information Management System (LIMS)
* Microbiological testing lab experiencein thepharmaceutical industry
* Knowledgeof GMP, ISO standards, andregulatory/corporate requirements
*Years of Experience*
* 1 – 2 years
* 2 years
*A Career That Matters*
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
**Organization:** **Global Quality – US/Canada Operations*
**Title:** *Microbiologist- Midnight*
**Requisition ID:** *18000LK5*