Specialist, Quality Assurance

Posted 8 Days Ago
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Hiring Remotely in IND
Remote
Mid level
Healthtech • Pharmaceutical
The Role
The Quality Assurance Specialist develops quality systems, ensures compliance with regulations, conducts root cause analysis, and mitigates operational risks.
Summary Generated by Built In

Job Description:

Quality Assurance is responsible for developing and implementing compliant and cost-effective quality systems that ensure products and services are reliable, safe and effective.

  • Demonstrates knowledge of quality systems and approaches.
  • Demonstrates an understanding of the relevant regulations, standards and operating procedures.
  • Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.
  • Demonstrates an understanding of the requirements and could perform gap assessments to those requirements.
  • Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.
  • Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.
  • Applies concepts of the Operational Risk Management Framework discipline to identify and mitigate risks.
  • Exposure to SAP/ECC & MDM/MDG (Product Master data management awareness would be a plus)
  • Awareness on SOX Controls

Qualifications

  • Bachelors in related field, or equivalent work experience, preferred
  • 4+ years’ experience in related field, preferred

What is expected of you and others at this level

  • Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
  • Works on projects of moderate scope and complexity
  • Identifies possible solutions to a variety of technical problems and takes actions to resolve
  • Applies judgment within defined parameters
  • Receives general guidance 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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