Quality Associate I

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.

JOB PURPOSE:

Coordinate perform and provides technical support in the submission of Field Alert Reports (FAR) and Field Corrective Actions (FCA) related to Jayuya products. Support Complaint investigations and follow up until implantation of corrective actions associated to FAR/FCA. Supports and follow up corporate holds associated with FAR/FCA. Supports and follow up in the samples requisitions and related protocols for products impacted by a FAR or a FCA. Assists and support the activities of audits documentation functions for external and internal audits. Assures that the Baxter Jayuya facility complies with all internal and external applicable standards for areas of responsibilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Coordinate manage review the information and follow up Field Alert Report (FAR) at the Facility.

• Coordinate manage review the information and follow up Field Corrective Action (FCA) at the Facility.

• Coordinate and follow up complaints investigations and samples evaluations related to FCA & FAR.

• Coordinate/ generate and follow up corporate holds associated with FAR/FCA.

• Coordinate/ Supports and follow up in the samples requisitions and related protocols for products impacted by a FAR or a FCA.

• Handling and follow up commitments for FCA and FAR processes.

• Prepared and document the Management Review and Quality Data Review with regards to FCA & FAR.

• Provide the reports to the appropriate company groups on time.

• Performs changes to procedures for areas of responsibilities.

• Supports in the handling of information requests from other companies or countries with regards to product included in a FCA.

• Coordinate participate and perform communication meetings or teleconference with company departments or facilities as required.

• Fill out files and controls all related documentation for areas of responsibilities assuring the compliance with all standards and company retention requirements.

• Support the FDA readiness plan.

• Provide supports to the Quality Assessment Manager during the FDA inspections ISO suppliers clients and other audits when required.

• Support and perform Internal Audits as required.

• Team worked oriented.

• 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 prepared and /or provide training when required.

• Support other department as required.

QUALIFICATIONS

• EDUCATION and/or EXPERIENCE

Bachelors degree in Sciences (B. S.) or Business Administration (MBA preferred); two to four year of previous experience in Quality and Manufacturing areas; computer knowledge (Word Power Point Excel Trackwise). Qualify Auditor Certification preferred. Excellent communication skills. LEAN Knowledge (prefer).

Knowledge in regulatory standards as ISO 9001: current version FDA Regulations current version and ICH.

US Benefits at Baxter (except for Puerto Rico)

This is where your wellbeing matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and wellbeing benefits include medical and dental coverage that start on day one as well as insurance coverage for basic life accident shortterm and longterm disability and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount and the 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching. We also offer Flexible Spending Accounts educational assistance programs and timeoff benefits such as paid holidays paid time off ranging from 20 to 35 days based on length of service family and medical leaves of absence and paid parental leave. Additional benefits include commuting benefits the Employee Discount Program the Employee Assistance Program (EAP) and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site: Benefits Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

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