Specialist-I, Supplier Quality - Jobs in Alliston, ON

Job Description

This is where you save and sustain livesAt 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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters 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.SummaryResponsible for the Alliston Supplier Assessment Program, ensuring compliance to Corporate Quality Manual, Health Canada, Corporate and ISO requirements.Schedules, coordinates and performs Supplier compliance audits per schedule.Creates audit reports based on assessment findings and reports to management representative.Utilizes the Quality Trackwise® System (TW) for audit records.Utilizes the Supplier Quality Management System (SQMS) in Trackwise® for maintaining Supplier Quality Records. Conducts Supplier Quality re-evaluations. Communicates with Suppliers to obtain required information and/or documents. Understands and assures conformance to regulations for Suppliers.Manages the Quality approval for all Supplier corrective actions (internal and external).Manages the Supplier notice of change process for the facility.Requires up to 15% travel, including potential international locations.Main responsibilities

• Ensure Supplier assessment program is compliant to Corporate Quality Manual, Health Canada, Corporate and ISO requirements.
• Schedules and coordinates inspections with Suppliers.
• Performs Supplier compliance audits per schedule.
• Reviews and analyzes audit results.
• Utilizes the Trackwise system to maintain audit documentation and track audit completion.
• Utilizes the Supplier Quality Management System in Trackwise to maintain Supplier Quality records.
• Conducts Supplier Quality re-evaluations.
• Communicates with suppliers to obtain required information and/or documents.
• Understands and assures conformance to regulations for Suppliers.
• Prepares and coordinates supplier risk programs for non-compliant suppliers as applicable
• Collaborates with business partners to understand new supplier needs and advise/support to supplier set-ups.
• Maintain ASQ Certification status.

• Manages the Supplier Quality approval for all internal and external supplier corrective actions initiated (SCARS, ICARS).
• Manages the Supplier Notice of Change (SNC) program for the facility.

• Remains current with respect to regulatory trends and divisional issues.
• Partners with facilities, divisions, and regions to ensure successful implementation and compliance to CQP/regulations.

• Completes requested month end summary/metric reports for Management Review meeting.

JOB REQUIREMENTSEducation LevelRequired:

• Bachelor of Science

Preferred:

• ASQ Certified Quality Auditor

Major Subjects / SpecialtiesRequired:

• Science (Chemistry, Microbiology, Pharmacy, Engineering)

Preferred:Type of ExperienceRequired:

• Manufacturing & Quality background
• Previous experience in a GMP environment
• Knowledge of GMP, ISO and Regulatory standards

Preferred:

• Previous experience 3-5 yrs Supplier Quality Audits
• Supplier Management
• Supplier Quality Agreements
• Knowledge of Corporate Quality requirements
• Lead auditor training with experience in auditing techniques

Years of ExperienceRequired:

• 2 – 3 years experience in a pharmaceutical environment

Preferred:

• 5+ years of successful experience in a pharmaceutical environment

Additional Skills / Special Training / Technical Skills RequiredRequired:

• 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.

Preferred:

• Ability to support our transformation to a LEAN enterprise through the application of LEAN tools.
• Proficiency in Trackwise® System
• ASQ Certification.

#LI-AR1#IND-CAReasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.078935Quick Apply

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