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
3 plus years of relevant work experience in a GMP related Industry / Quality operations / Pharmaceutical applications
Strong problem solving, critical thinking and analytical skills
Ability to prioritize multiple tasks
Knowledge and application of computer systems for word processing, reporting, data analysis and complaint management
Ability to proactively initiate and implement continuous quality improvement
Excellent written/oral communication and organizational skills
Ability to work autonomously
Reasonable Accommodations
Baxter 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.
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