Quality Specialist

2 weeks 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**

As s Quality Specialist you will perform the quality functions at the Center for Intravenous Admixtures (CIVA) by providing support and guidance to ensure implementation of Quality Systems and compliance with pharmacy guidelines, Baxter corporate policies, SOPs, applicable regulatory requirements and customer requirements. Monitor compliance through ongoing reviews and implement continuous improvements.

**What you'll do**
- Ensure implementation of the Quality System at the CIVA Centre
- Develop, implement and maintain Quality systems and standards
- Review government, regulatory, ISO and corporate policies to ensure all local procedures are current and meet the requirements
- Identify compliance gaps and develop plans to address compliance gaps.
- Develop SOPs and ensure implementation of the SOPs
- Review, track and process CIVA Standard Operating Procedures (SOP)
- Liase with Product Surveillance to effectively process complaints
- Complete evaluation of complaint samples, perform manufacturing record review and investigations, as necessary
- Initiate/Assess/Track Change Control in Trackwise 8
- Review Change Control documentation for new service codes
- Manage document change control process in TcU
- Provide support for the initiation, timely completion and closure of NCR/CAPAs in Trackwise 8
- Provide support for the initiation, timely completion and closure of CPIs
- Identify/Implement corrective and preventive actions and evaluate effectiveness
- Coordinate processing of products affected by holds and/or FA
- Ensure applicable CIVA suppliers and finished goods/materials are approved in GSQTS
- Develop Quality Agreements with CIVA suppliers
- Evaluate Supplier Corrective Action Report (SCAR) responses
- Quality/Regulatory Audits
- Develop and conduct Quality related training programs (e.g. cGMP, GDP, SOPs)

**What you'll have**
- Bachelor of Science Degree
- Strong problem solving, critical thinking and analytical skills
- Ability to prioritize multiple tasks
- Ability to proactively initiate and implement continuous quality improvement
- Excellent written/oral communication and organizational skills
- Ability to work autonomously

**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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