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Principal Specialist, Quality Assurance

Company: Cardinal Health
Location: Indianapolis
Posted on: March 28, 2020

Job Description:

At Cardinal Health, we're developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities. What a Principal Specialist, Quality Assurance contributes to Cardinal Health - Reports to Manager, Quality Assurance. - Principal Specialist, QA is responsible for insuring quality standards and procedures are followed and will be in charge of quality monitoring and assurance to ensure that all products manufactured are of the highest quality possible. Inspection and quality assurance activities to meet specifications and quality standards for variety of in-process and finished products. Authorized to inspect products to ensure the required quality standards are met. 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. - Contributes 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. - Responsible for being a culture champion by participating in the development, monitoring and sustainment of the culture that is an integral part of the site philosophy and vision. The incumbent is responsible for embracing and demonstrating the culture of energy, passion and positive atmosphere while delivering superb customer service. Accountabilities - Inspecting and sampling of product throughout the manufacturing process. - Assist in determining types of tests to be performed as well as documentation and reporting requirements. - Interact regularly with manufacturing and service functions to establish quality standards for raw material, work in process, and finished products. - Champion Quality, GMP compliance and EHS/Radiation Safety practices. - Develop and lead GMP/GDP training of all employees. - Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems. - Assists in the release of the final product in compliance with applicable regulations (FDA, EU, etc.) and marketing authorizations. - Responsible for the review and dispositioning of incoming raw materials and components. - Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements. Responsible for approval of minor Quality Events. - 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(s). - Understands technical/release product issues and evaluate their potential impact on product quality and compliance. - Provides ideas for continuous improvement of the GMP 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. Performance Expectations - Models the characteristics outlined in the Cardinal Health Leadership Essentials- Professional and Business Support. - Demonstrates a commitment to the organizations mission, vision and values supporting organizational decisions and behaviors. Contributes to the development and implementation of systems and processes ensuring strategic goal attainment. - Works as part of a team with others and shows respect and values diversity toward others. - Demonstrates efforts to discovering, meeting and advocating for the customers needs. - Takes actions to continually improve quality and safety in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback. - Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements. - The ability to act calmly and patiently when working under pressure and/conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives Qualifications - Requires Bachelors in related field, or equivalent work experience, preferred - Preferable to have 2-10 years of experience in pharmaceutical industry Quality Assurance environment supporting US FDA and International pharmaceutical products. - Possess an understanding of cGMP/compliance requirements for cosmetic or pharmaceutical products. - Attention to detail. - Ability to manage timelines and priorities. - Ability to work independently with minimum guidance. - Ability to multi-task. Physical/ Mental Requirements - The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. - While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds. Work Environment - The primary work environment consists of an office, warehouse and production environments within a radiopharmaceutical manufacturing facility. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate. 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.

Keywords: Cardinal Health, Indianapolis , Principal Specialist, Quality Assurance, Other , Indianapolis, Indiana

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