Quality Specialist
Quality Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
This is whereyour work makes a difference.
At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.
Here you will find more than just a jobyou will find purpose and pride.
Perform the quality functions at the Center for Intravenous Admixtures (CIVA) by providing support and guidance to ensure implementation of Quality System and compliance with pharmacy guidelines Baxter global policies SOPs and applicable regulatory requirements. Monitor compliance through ongoing reviews and implement continuous improvements.
- Develop implement and maintain Quality Systems and standards at CIVA
- Review government regulatory and Baxter global policies to ensure all local procedures are current and meet requirements
- Identify compliance gaps and develop plans to address gaps
- Develop SOPs and ensure implementation
- Manage and maintain organization of all quality documents
- Prepare metrics for Monthly and Quarterly reports as required
Change Control
- Initiate/Assess/Track Change Controls in Trackwise 8
- Review Change Control documentation for new service codes
- Manage document change control process in TcU
- Own Change Control records and tasks
NCR/CAPA/Exceptions
- Provide support for the initiation timely completion and closure of NCR/CAPAs in Trackwise 8 and PQIs in CQI
- Identify/Implement corrective and preventive actions and evaluate effectiveness
- Track and trend NCRs/CAPA/exceptions
- Provide appropriate product disposition
Complaints
- Log and track external and B2B complaints
- Liase with Product Surveillance to effectively process complaints
- Manage the return of complaint samples
- Complete evaluation of complaint samples perform manufacturing record review and investigations as necessary
- Update metrics
Supplier Quality
- Ensure applicable CIVA suppliers and finished goods/materials are approved in GSQTS
- Evaluate Supplier Corrective Action Report (SCAR) responses
- Track timely closure of corrective/preventive actions
- Perform PEGA sign off of new codes as needed
Hold Management and FA
- Facilitate timely completion for response to Hold/FA notification
- Coordinate processing of products affected by Holds and/or FAs
- Manage CIVA quarantine process
Quality/Regulatory Audits
- Host/Participate in audits at CIVA
- Perform internal audits at CIVA
- Develop and conduct Quality related training programs (e.g. cGMP GDP SOPs)
- Provide Quality support to various CIVA Projects
- Perform other Quality duties as assigned
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.
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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
