QC Microbiology Compliance Specialist (24 months)

You are driven by the knowledge that the products you help make saves and sustain lives. You can move quickly, address questions, and encourage teammates, all while getting quality products out on time. You are calm, positive, and a key part of a fast-paced environment that emphasizes camaraderie and teamwork. As a QC Microbiology Compliance Specialist, you are happiest when you are moving, and we will not disappoint!  

Baxter is known for its speed and high-quality product. Our manufacturing operations are around-the-clock to meet the needs of our customers. Our high-caliber talent works through the challenges at hand while pushing toward meeting client order needs. We are currently looking for a Microbiologist to work a 24-month, full-time contract position on our Day shift (Monday to Friday 8:00h-16:30h EST), at our Alliston facility!

What You'll be Doing:

• Responsible for coordinating with the Microbiology Manager and Supervisors to ensure compliance to required timelines for the completion of all Microbiology NCRs, CAPAs, OOLs and training.
• Schedules, coordinates and performs investigations associated with Microbiology data non-conformances with all involved Microbiologists.
• Determines through observations, in-depth employee interviewing and flow charting, the issues and elements of the process or system which potentially prevent an individual from performing a function correctly or act as a deterrent to the proper performance of the function.
• Monitors Microbiologists training status to maintain compliance to the training curriculum.
• Monitors the status of review for the lab to ensure that all records are complete and up to date.
• Tracks batch release dates to ensure that the lab is on target to meet dates.
• Performs document changes for the laboratory.
• Supports completion of CAPA tasks.
• Tracks all CAPAs to closure ensuring timeliness of all actions including correction/containment, investigation, corrective/preventiveactions/effectiveness and closure.
• Reviews Corporate Quality Procedures and policies and new/revised Health Canada guidance documents/regulations to ensure local procedures are maintained appropriately.
• Performs instructor led training with the Microbiologists.

• Creates trending reports for product results and environmental monitoring.

What You'll Bring:

• University Degree, Bachelor of Science
• Experience in writing OOL and/or non-conformance investigations
• Manufacturing & Quality background
• Previous experience in a GMP environment
• Knowledge of GMP, ISO and Regulatory standards
• 2 – 3 years experience in a pharmaceutical environment
• Strong understanding of Health Canada GMP and Medical Device Regulations.
• Thorough knowledge of applicable procedures, specifications, regulations and standards.
• Strong process and project management capabilities.
• Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization.
• Ability to build strong relationships with internal and external customers.
• Strong ability to balance multiple priorities.
• Role model personal accountability for results and integrity and relentless focus on rapid and disciplined action.
• Strong analytical and problem solving skills and critical thinking abilities.
• Intermediate to Advanced proficiency in Word, Excel, Powerpoint.
• Must interpret regulations and standards based on good quality practices and good business requirements.
• Must be able to build good relationships with internal and external customers.
• Maintain technical expertise and method/procedure knowledge to support good decision making.
• Maintain quality and patient safety first while recognizing the importance of good business decisions.

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