Job Description

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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxters 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.

SUMMARY:

Execute all CAPA System process related activities within the facility including, identification of nonconformances associated with Baxter products and processes, the investigation of root cause, correction/containment, corrective/preventive action, verification of effectiveness and closure within Global Procedure requirements. Perform root cause investigation and corrective/preventive action activities within prescribed timelines. Report on system progress and metrics. Compile, prepare and present information to the facility CAPA Review Board/ Tier board structure. Train and/or mentor site personnel on the CAPA System process to maintain compliance to regulatory and global requirements.



ESSENTIAL FUNCTIONS:

FUNCTIONAL RESPONSIBILITIES



* Responsible for conducting on nonconformance root cause investigation, containment corrective/preventive action, verification of effectiveness and closure activities.

* Identify, implement, and monitor process improvements to ensure continuous improvement to product and process quality.

* Mentor/Coach Investigation Owners in developing investigation plan, results corrective actions and effectiveness checks.

* Compile, prepare and present information to the facility CAPA Review Board. Maintain CRB information per established requirements.

* Facilitate facility conformance and required action activities to ensure timeliness of completion.

* Verify respective functional activities for each record are complete: Root Cause Analysis, Containment, Corrective Action, Preventive Action, Validation, Verification of Corrective/Preventive Action, Effectiveness Check and closure of completed.

* Update procedures, work instructions and processes through approved change control processes.

* Qualify as a site trainer, develop and provide training when needed. Maintain user system access process

* Perform assessments or other correction, corrective action, preventive action processes

* Perform other duties as assigned



QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED:



* This role requires extensive personnel interaction, including all functions levels of the organization.

* Must have computer proficiency with solid experience in Microsoft Word, Excel, Minitab and Access or other database programs.

* Ability to work effectively as part of a cross functional team

* Excellent organizational and presentation skills

* Attention to detail

* Ability to multi-task and work well under pressure.

* Understand scientific strategies and be able to invent new methods or new avenues of investigation

* Good interpersonal/communication/influencing/negation/ training/ project management skills.

* Working knowledge of FDA Regulations, ISO Regulation(s), and Application of Good Manufacturing Practices.







IV.EDUCATION/EXPERIENCE REQUIRED:

* BS in science/engineering or equivalent, MS in science/engineering a plus.

* 2+ years experience in quality with a medical device/pharmaceutical company or similar regulated industry, preferred.

Working knowledge of Quality Systems and related requirements and standards, including 21 CFR Part 820, 21 CFR Part 11, ISO 13485, preferred.

Strong knowledge of risk management, root cause analysis, corrective and preventive action and document control.

Demonstrated use of quality and root cause analysis tools, principles, and methodologies including statistical tools.

This role requires extensive personnel interaction, including all functions and all levels of the organization; candidate must be able to work well with all functional areas within the company.

Must be able to author and implement procedures in response to corrections or corrective actions.

Must have computer proficiency with solid experience in Microsoft Word, Excel, Minitab and Access or other database programs. TrackWise proficiency and experience, a plus.

Ability to work effectively as part of a cross functional team, should possess advanced organizational skills, presentation skills, and verbal/written communication skills. Attention to detail required



PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



While performing the duties of this job, the employee:

* Must be able to stand, sit and walk throughout the work day.

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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

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.