Quality Associate Ii (Auditor)

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.

JOB PURPOSE

Coordinate, perform and provides technical support for the Internal Audit Program. Assists and support the activities of audits, documentation functions and general assessments/audits program for external and internal audits. Assures that the Baxter Jayuya facility complies with, all internal and external applicable procedures, regulations, standards, inspection guidelines, etc..

ESSENTIAL DUTIES AND RESPONSIBILITIES

Coordinate, manage and follow up the Internal Audit program.

Prepare and publish the Annual Internal Audit schedule and assure the compliance.

Audits all areas assuring the compliance with all internal procedures, applicable external regulations and applicable standards (e.g. cGMP's, cGDP's, ISO std).

Assure that the audit readiness plan is maintain and deploy.

Support remediation compliance programs.

Assists in planning and developing assessment strategy and logistics.

Identifies possible Regulatory Risks within the Baxter Jayuya operations and notified to management.

Provide supports to the Quality Compliance – Audit Manager during the Company Internal and External Audits as FDA inspections, ISO, suppliers, clients and other audits.

Prepare, perform and review Audit and departmental reports on time.

Review and evaluate the observation response for internal audits.

Support and perform the plant annual FDA 483’s Certification.

Handling and follow up the commitments for external audit observations until completion.

Perform and support Quality Management System activities required or assigned to assure the facility compliance.

Administrate reviews and updates the Plant Quality Manual and other applicable reports.

Perform and handling the Corporate Quality Procedure Compliance Program (GQP-CoC).

Performs changes to procedures for areas of responsibilities.

Writes corrective actions found and keeps track of them before and after internal and external inspections and audits; assures that company makes all changes necessary to comply with all regulations, standards and procedures.

Manage and use the applicable software application (Trackwise).

Team worked oriented.

Coordinate and perform meetings and documented the minutes, when required.

Able to work under minimum supervision and to handle multiple tasks at the same time.

Occasionally required to work extra hours, Holidays (e.g. shutdowns, FDA Audits, ISO 9001 Audits, Pharma Partner audits and Due Diligence audits.

Able to provide training related to areas of responsibilities, when required.

Perform and participate in communication or teleconference with other company departments or facilities when required as part of the responsibilities.

Perform the reports related to Quality Data Review and Management Review, provide the information on time, analysis the results and prepare the evaluation report. Participate and present the information in the appropriate meeting.

Provide support in other department areas, when required.

Keeps associates oriented on regulatory issues.

Willing to travel.

QUALIFICATIONS

EDUCATION and/or EXPERIENCE

Bachelor's degree in Sciences (B.S.) or Engineering; threeto five years related quality audit experience. Knowledge of Federal and Local regulations (such as: FDA, ISO / EN). Computer knowledge. Experience in managing Standard Operating Procedures (SOP’s) and documentation audit programs. Excellent interpersonal skills, communications skills (verbally, written, visual). Knowledge of Microsoft Office (Word, Excel, Power Point, etc.). Knowledge in Six Sigma, Lean, and statistics are desirable.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.
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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.

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