Cardinal Health Principal Specialist, Quality Assurance in Aurora, Colorado
What Quality Assurance contributes to Cardinal Health
Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures 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 has the ability to 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.
- Provides general oversight of Contract Manufacturing Organizations (CMO) with primary focus on the review of production records and release to market of finished products.
- Represents QA in meetings related to his/her area of responsibility (i.e. CMO meetings, new product launch meetings, audit planning/review, budget planning)
- Handles coordinating and negotiating supplier Quality Assurance Agreement (QAA) commitments prior to QRA Management approval of the QAA..
- Acts as point of contact for technical and product release issues with responsibility for the evaluation of issue impact on product quality and compliance. Manages approvals of minor Quality events and escalates major issues or concerns to QRA management in a timely manner.
- Other duties and projects as assigned
- Bachelor's in related field, or equivalent work experience, preferred
- 4+ years of experience in related field, preferred
- Experience working with FDA strongly preferre
- Strong knowledge of 21 CFR210/211
- Past experience managing Quality Assurance agreements strong preferred
- Past experience with review and release of production records
- Proficient in Microsoft Office Applications
What is expected of you and others at this level
- Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
- May contribute to the development of policies and procedures
- Works on complex projects of large scope
- Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
- Completes work independently receives general guidance on new projects
- Work reviewed for purpose of meeting objectives
- May act as a mentor to less experienced colleagues
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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Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.