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Quality Associate III

Quality Associate III

BaxterCataño, Cataño
Hace 11 días
Descripción del trabajo

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.

Your role at Baxter

Position is responsible for the implementation, deployment and maintenance of the Quality System throughout the organization and assuring that all applicable government regulations and Baxter’s Quality Assurance and Regulatory Affairs’ requirements are met and translated into local operating procedures.

What we offer from day 1

Medical, Dental, Disability and Life Insurance coverage

Vision Plan

Paid Vacation Days and Paid Holidays

Paid Parental Leave

Retirement Plan 165e

Employee Stock Purchase Program

Educational Assistance Plan

What you'll be doing

  • Support management to identify and escalate issues
  • Perform trend reporting and escalate results to appropriate business units for consideration of necessary actions
  • Participate in process improvement activities and projects
  • Ability to perform all duties required of previous levels.
  • Support management in activities of the Quality unit.
  • Manage Complaints, FCA’s, and Product Surveillance systems for products and services provided. Implements quality system and regulatory procedures and assures compliance to requirements.
  • Understands and assures conformance to local, federal and government regulations (including those of markets outside the US) as applicable to sales and distribution centers. Interfaces with personnel from regulatory agencies during inspections.
  • May participate in or manage quality assessments of internal operations, suppliers and third-party logistic supplier to analyze compliance and assess risk.
  • Interacts frequently with functional peers and senior group managers.
  • May interactions with regulatory agencies representatives and customers to represent the company products and processes.
  • Conduct analysis of written procedures and submit procedural changes as needed to meet corporate, divisional, and regulatory requirements
  • Self-motivated with the ability to work independently and make decisions.
  • Excellent organizational skills, problem solving skills and attention to detail.
  • Ability to perform multiple tasks simultaneously and work cross-functionally in a highly-matrixed environment.
  • Ability to drive decisions and actions.
  • The incumbent will perform other duties assigned.
  • Responsible to inform unsafe behaviors and also recommend safety measures to the appropriate department
  • Ability to prefer and implement all the validation as required.

What you'll bring :

  • Minimum of associate's degree required in nursing, pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN). Bachelor’s degree and / or clinical certification (MT, RN) preferred. Preferably with 0-3 years’ work experience in a cGMP industry environment.
  • Strong interpersonal skills and great attention to detail are necessary.
  • Must be a strong team player with good problem solving, and good verbal and written communication skills. Must have the ability to encourage teamwork.
  • Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, and Application of Good Manufacturing Practices.
  • Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change

    US Benefits at Baxter (except for Puerto Rico)

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