Specialist. Quality Compliance

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Guaynabo, PRI
In-Office
Healthtech • Pharmaceutical
The Role

What Quality Compliance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Compliance is responsible for the development and deployment of policies, procedures and programs designed to minimize risk, enable compliant business operations, products and services and drive uncompromised supply chain integrity.
Responsibilities

  • On site support for Quality Management Systems (QMS) to drive performance improvement and enhance supply chain integrity.
  • Perform non-conformances investigations, root cause analysis, and development of CAPAs.
  • Assist in the product quality complaints process for distribution.
  • Review and/or approve Temperature & Humidity reports for thermostatically controlled storage environments.
  • Facilitate quality-related training, as needed.
  • Served as the backup of the Recall Coordinator.
  • Assist with internal/external audits and regulatory inspections.
  • Report quality metrics, ensuring timely updates to dashboards, logs, and management reviews.
  • Provide ongoing guidance and direction to operations personnel regarding regulatory and quality matters.
  • Participate in continuous improvement initiatives and contribute to quality culture development.
  • Work on or may lead complex quality projects of large scope.
  • Perform other job duties as assigned

Qualifications

  • Bachelors in related field, or equivalent work experience in related field
  • 2 years of experience in related field is preferred
  • Proficient in Microsoft Office programs
  • Possess strong technical writing and verbal communication skills.
  • Bilingual (English and Spanish) Written is required for this role

What is expected of you and others at this level

  • Collaborate with others and understand how to be successful in a Team environment.
  • Detail oriented, strong organizational skills, able to multi-task, a self-starter, and self-motivated.
  • Apply working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
  • Work on projects of moderate scope and complexity
  • Identify possible solutions to a variety of technical problems and take action to resolve
  • Apply judgment within defined parameters
  • Receive general guidance and may receive more detailed instruction on new projects
  • Work reviewed for sound reasoning and accuracy

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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The Company
HQ: Dublin, OH
44,000 Employees
Year Founded: 1971

What We Do

Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. With 50 years in business, operations in more than 35 countries and approximately 44,000 employees globally, Cardinal Health is essential to care. We are navigating the complexities of healthcare and providing scaled solutions to help our customers thrive in a changing world. We strive to be a trusted healthcare partner by driving growth in evolving areas of healthcare, while building upon our distribution, products, and solutions to meet customer needs.

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