Quality Control Microbiologist I - Day

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.