Sr. Spec, Quality ECM
Sr. Spec, Quality ECM
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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.
- Act as Quality contact for assigned External Contract Manufacturer (ECM) partnerships.
- Work with new ECM partners to ensure they meet Baxter quality requirements.
- Assist with the negotiation development and maintainance of Quality Agreements between ECM and Baxter.
- Work with Product Quality and Design Quality to execute technical transfer activities to ECMs.
- Manage Quality and Compliance related issues between ECM and Baxter.
- May participate in Health Authority inspections and Baxter audits of ECM to ensure successful inspection outcomes and maintain a constant state of inspection readiness at ECM sites.
- Perform quality risk assessments; develop mitigation actions and follow-up on CAPA implementation and monitor quality/process improvement initiatives at the ECM.
- Define applicable metrics for new ECMs. Monitor and report quality performance metrics for established ECMs.
- Ensure timely change implementation deviation/investigation review complaint investigations and CAPA closures at the and approve Annual Product Quality Review (APQR) reports for Baxter products manufactured at ECMs
- Escalate and manage ECM issues within the Baxter Field Action process
- Work with Baxter employees across multiple global sites and functions to assess the impact of an ECM Supplier Notice of Change (SNC).
- Perform Baxter batch release for product at ECM sites.
- Set and monitor quality system requirements to suppliers within the Finished Good and Contract Manufacturing space.
- Execute SCAR management ensuring effective and timely closure. Assess quality notifications from ECMs and determine if escalation to SCARs and NCR is neededImprove/develop quality systems at selected suppliers for QMS and compliance improvement
- Support Supply Chain Regulatory Quality and Purchasing organization for third party suppliers related activities as applicable
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:
Senior IC
Employment Type
Full-Time
