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Baxter International Inc. · 8 hours ago

Associate I, Quality

Byhalia, Mississippi

Full-time

Onsite

Entry Level

$64K/yr - $88K/yr

1+ years exp

Baxter International Inc. is dedicated to improving healthcare outcomes for patients worldwide. The Quality Associate I is responsible for providing quality support to the Global Logistics Center, including product inspections, procedure updates, and ensuring compliance with GMP/QSRs requirements.

BiotechnologyClinical TrialsHealth CareMedical

No H1B

Responsibilities

Perform physical inspection of products and comparison/assessment to all related documentation within the warehouse as needed (certificate or analysis, packing list, bill of lading, Temptale management, etc.)

Initiate procedure revisions as needed to support continuous improvement. Ensure that procedures are current and that facility employees perform tasks according to procedures through direct observation

Activate, distribute and file procedures related to both local and corporate changes

Manage official forms distributed throughout the facility

Support assigned activities to ensure compliance with the Baxter COI program

Collaborate with the Training Administrator to ensure training requirements are met prior to activation of all procedures

Manage the state licensure program to ensure no licenses expire

Support Temperature Monitoring of the MGLC Warehouse which includes operating the Rees system, reporting all temperatures on a spreadsheet for daily management review and uploading data from the backup digital data loggers throughout the facility. Investigate and resolve any Rees system alarms and document monthly MKT requirements

Manage the document retention program

Support assigned responsibilities for document tracking and overall facility documentation control

Prepare monthly Quality Management & Data Review Presentations

Perform Internal Assessments for continuous improvement of MGLC Quality Systems

Assist other members of the Quality Department and facility management team to ensure timely closure of any audit observations

Serve as a back-up for processing local hold requests using the Warehouse Management System (WMS) and JD Edwards (JDE) systems as needed

Serve as a back-up for processing corporate FCA hold requests using Cardinal Health’s FCA Tracking System, Baxter’s Warehouse Management System (WMS) and Baxter’s JD Edwards (JDE) system. Conduct audits of FCA hold product

Serve as a back-up for processing product dispositions linked to local and corporate holds and report through the appropriate people and systems to ensure timely response/closure

Perform manual product releases after verification of release by manufacturing plant in Batch Release System (BRS) as necessary

Support all lean implementation initiatives in the Quality Department and throughout the facility, including periodic 6S audits and closure of any assigned action items

Work in collaboration with other members of the Quality Department to prepare for internal and external auditors

Support the Quality Department by completing other duties, projects and/or tasks that may be assigned as needed

Qualification

FDA RegulationsManufacturing PracticesQuality Management SystemsDocument ControlInterpersonal SkillsProblem SolvingVerbal CommunicationWritten Communication

Required

Bachelor's degree or Associate degree required

Minimum one year of relevant experience

Strong interpersonal skills and great attention to detail are necessary

Must be able to handle multiple projects concurrently

Knowledge of FDA Regulations, Application of Good Manufacturing Practices

Must be a strong team player with good problem solving and good verbal and written communication skills

Preferred

Experience with a medical device/pharma or other similarly regulated industry preferred

Benefits

Paid Time Off and Paid Holidays

Medical, Dental, Disability and Life Insurance coverage

Vision and Voluntary Benefits

Paid Parental Leave

Retirement Savings Plan

Employee Stock Purchase Program

Flexible Health Care Spending Accounts

Educational Assistance Plan

Employee Discount Program

Employee Assistance Program (EAP)

Childcare benefits

Company

Baxter International Inc.

Glassdoor3.7

For nearly a century, we have delivered on our commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world.

Founded in 1931

Deerfield, Illinois, USA

10001+ employees