Principal Specialist, Quality Assurance

Cardinal Health•Indianapolis, IN

44d

About The Position

Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. QA Principal Specialist is responsible for ensuring quality standards and procedures are followed and will oversee 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.

Requirements

Bachelor's degree in related field, or equivalent work experience, preferred. Advanced Degree may be preferred
4-8 years' experience in related field, preferred
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

Responsibilities

Inspecting and sampling of product throughout the manufacturing process.
Establish and maintain quality control procedures.
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. Follows/ mentors GDP/GMP requirements.
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.
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.