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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

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Oversees FCA’s (Field Corrective Action), Complaints, FAR’s (Field Alert Reports) and Hold processes for the Aibonito Manufacturing facility.  Support External & Internal Audit Program and Supplier Quality Program.  Creates, improves and audits SOP's and Protocols to assure that areas are in compliance with all internal specifications and regulatory requirements.

Coordinate, review and supervise the information and follow up of the Complaint Handling System (CMS) at the Facility.

Provide technical support in complaints investigations, including customer meetings and/or sales representative contacts in product use impact

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

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

Coordinate and follow up complaints investigations and samples evaluations.

Coordinate/ generate and follow up corporate holds. 

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

Handling and follow up commitments for FCA, FAR and Complaint processes.

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, FAR or Complaint.

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

Support the FDA readiness plan.

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

Performs department budget in accordance to all area needs.  Create and manage Capital Approval Projects Assuring that all resources are maximized in a safety and quality manner.

Performs weekly, monthly and annual reports as required by Plant Senior Management, policies and procedures.

Willing to Travel

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  List knowledge, skills, and/or abilities required. 

Proficient in Microsoft Office

Bilingual (English/Spanish)

Ability to analyze and interpreting results.

Communication skills. Problem solving skills.

Teamwork oriented. Good people skills. Customer interaction required.

Education and/or Experience

Bachelor Degree in Pharmacy;   Pharmacist license is required.

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.