Specialist-i, Quality Compliance

3 months ago

Alliston, Canada BAXTER Full time

**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 lives—where your purpose accelerates our mission.

SUMMARY OF RESPONSIBILITIES

Responsible for the Alliston Supplier Quality Program and Internal Audit program, ensuring compliance to Corporate Quality Manual, Health Canada, Corporate and ISO requirements.

**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**:

- Ensures audit program is compliant with Health Canada, Corporate, and other applicable quality requirements.
- Schedules and coordinates audits/inspections with internal customers and supplier.
- Performs internal and supplier compliance audits per schedules.
- Reviews and analyzes audit requests.
- Maintains internal system to track outstanding issues and to allow for preparation of audit reports for management review.
- Utilizes appropriate software (eg. Trackwise®) to input and maintain audit and Supplier Quality records and to track audit completion.
- Coaches Internal audit participants and supports development of appropriate corrective actions.
- Manages Internal Audit Program in compliance with Health Canada, Corporate, and other applicable quality requirements.
- Conducts Supplier Quality inspections and re-evaluations according to schedule.
- Overall coordination for all audits assigned: including audit strategy development, planning, identification of scope, and audit execution.
- Communicates with customers to obtain required information and/or documents.
- Promptly escalates Critical observations with the responsible operations and manager and Quality Management Representative.
- Prepares, issues and distributes Audit Reports.
- Reviewes proposed corrective actions (including their effectiveness check) for their content and evaluate whether these actions will be adequate to correct observations.
- Reviewes of implemented actions to confirm previous audit closure.
- Manages audit records within Baxter’s Quality Workflow Platform (QWP) Audit Module (Trackwise 9).
- Remains current with respect to regulatory requirements and trends, and divisional issues.
- Partners with facilities, divisions, and regions to ensure successful implementation of and compliance to regulations and corporate requirements.
- Coordinate external inspections, e.g. regulatory inspections, ISO Registrars, etc, by escorting the inspectors throughout the inspection processes
- Manages facility audit-readiness and trains other audite team members.
- Leads and participates in continuous improvement projects with the objective of achieving quality, reliability and cost improvement goals
- Completes requested summary/metric reports as needed, including Management Review meeting.

**Education Level**

Required:

- Bachelor of Science

Preferred:

- ASQ Certified Quality Auditor

**Major Subjects / Specialties**

Required:

- Science (Chemistry, Microbiology, Pharmacy, Engineering)

Preferred:
**Type of Experience**

Required:

- Lead auditor training with experience in auditing techniques
- Manufacturing and Quality backgroun

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