Quality Associate Iii

2 months ago

Mississauga, 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.

**Your role at Baxter**:
Responsible for providing Quality oversight and management of Kidney Care (KidneyCo) US warehousing and distribution operations, including renal fleet drivers, external warehousing partners (i.e., 3PL providers, wholesalers, freight forwarders and consolidation/ deconsolidation centers), and transportation providers. Able to prioritize multiple projects independently. Demonstrate efficiency in task completion, decision-making, empowerment of others, exception management, training, problem-solving and team leadership. A functional understanding of FDA requirements, ISO standards and the general QMS is required. _NOTE: This position will report into the Kidney Care (KidneyCo) UCAN Country QA/RA organization._

**What will you be doing**
- Provides leadership and mentorship in establishing quality standards, specifications and procedures for renal fleet operations, external warehousing partners, such as 3PL providers, wholesalers, freight forwarders and consolidation/deconsolidation centers
- Serves as primary Quality contact for external warehousing partners & transportation providers
- Conducts initial and ongoing audits/assessments of external warehousing partners
- Ensures compliance to corporate and local regulatory requirements regarding storage, handling and distribution of products
- Ensures new and emerging regulatory requirements associated with Good Distribution regulations are understood and disseminated to applicable locations
- Provides key data and inputs into UCAN Distribution quality processes (e.g., Management Review, CAPA Review Board)
- Investigates customer complaints to identify trends and process improvements
- Provides product dispositions when product quality issues arise (e.g., temperature excursions)
- Assists with management of US distribution licensing requirements
- Provides support for Canadian warehousing & distribution operations, as needed
- Works closely with UCAN Planning and Fulfillment organizations to meet business goals and objectives
- Manages activities to achieve defined quality goals in an efficient, accurate and timely manner
- Be directly involved in and where appropriate lead multiple process/product improvement projects
- Must be a recognized as a Subject Matter Expert and be able to demonstrate leadership ability
- Other duties, tasks, or projects as assigned

**Knowledge, Skills and Abilities**
- Excellent interpersonal/communication/presentation/negotiation skills
- Effective at influencing others to meet or exceed operations or quality key performance indicators (KPIs)
- Able to manage multiple projects and/or responsibilities simultaneously
- Solid understanding of FDA Regulations and Application of Good Distribution Practices
- Must have basic English written and oral communication skills adequate to connect with other team members
- Must be proficient with Microsoft Office and other data collection/analysis programs (e.g., Minitab)

**What do you bring**:

- Bachelor's degree required (preferably in science, engineering or equivalent field).
- Minimum of 5-8 years of experience in Quality, or related field in the medical products/pharmaceutical industry.
- 2-3 years of experience in lead auditor experience preferred
- Baxter is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission._**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter 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.

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