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Senior Specialist, Quality Assurance

  • Anywhere

Company :
Cardinal Health

Location :
Indianapolis, Indiana

Expiry Date :
Mon, 08 Mar 2021 23:59:59 GMT

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Description :
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 Accountabilities – Quality Assurance responsibilities include, but are not limited to, cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production and process controls – Establish and report metrics related products and processes – Establish and maintain quality assurance procedures – Champion Quality, cGMP compliance, and EHS/Radiation Safety practices – Actively partner with site management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems – Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements – Ability to network across business and functional units to achieve positive outcomes – Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the knowledge of the production process of the product – Understands technical/release product issues and evaluates their potential impact on product quality and compliance – Provides ideas for continuous improvement of the cGMP Quality Management System – Escalates complex issues to management in a timely manner – Prioritizes and ensures work is delivered in an efficient way – Performs other job duties as assigned Qualifications – Bachelors of Science (Chemistry or Biology preferred) or equivalent work experience – 2+ years experience in a regulated environment, pharmaceutical experience preferred – Possess an understanding of cGMP / compliance requirements for CFR 210/211 – Ability to work independently with minimum guidance 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 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. To read and review this privacy notice click here