Microbiologist - Contract
Baxter
Alliston, Ontario,Canada
32d ago

SUMMARY OF RESPONSIBILITIES

The Microbiologists work in different areas : 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.

GENERAL EXPECTATIONS

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

    D Time Spent Major Responsibilities / Activities 30% 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.Program the Datalogger (Digi or Validator 2000) for studies.

    Perform study. Run the study and record events. Analyze study data and printout. Record pertinent information. Perform experimental equivalency, cycle developments, Initials, 24pt.

    22pt., 2 year requals and 6 month vessel quals.Prepare protocol reports and write protocol section required for job. Also adding protocols in each study affected, before and after final report (Have to track the final report down and put a copy into each study affected).

    Autoclaves, PRTs, MRTs, Digi calibrated Quarterly.Vessel checks done quarterly and annually. 30% 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.

    10% 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. 5% Prepare, growth test and pH adjust a variety of media and buffer solutions, required for Sterility testing and Environmental monitoring.

    Rehydrate organisms and maintain stock cultures used for growth testing. 5% 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.

    5% 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. 5% 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.

    5% Maintain 6S within the lab areas assigned. Provide back-up coverage to the Sterility Assurance Department when needed.

    5% 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.

    Education Level Required :

  • University Degree, B.Sc. designation Preferred :
  • Preferred : Major Subjects / Specialties Required :

    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
  • 2 + years
  • 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.
  • 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)
  • Preferred :

  • Understanding of EMS through the application of LEAN tools in a laboratory environment
  • Technical writing skills
  • Quality

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