Senior Specialist, Quality Assurance Job
Job Description Job Attributes+
What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
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.
This role is responsible for managing the quality and regulatory reviews of Medical Distribution products, along with hazardous materials reviews for Pharmaceutical Distribution products. This role also provides support for executing the mission of Medical Distribution QRA, including technical support for Medical Distribution facilities encompassing all regulatory requirements (i.e. FDA, EPA, OSHA, DOT, etc.)
Perform a quality and regulatory review of product quality data for products being added to the Medical Distribution master file.Perform hazardous materials reviews for new items added to Pharmaceutical Distribution master file.Provide support for Medical Distribution field personnel relating to QRA topics and product quality data.Interact with cross-functional business partners (Supplier Relations, PDM, Operations, Category Management, Inventory, etc.) to assist in execution of the current Medical Distribution Quality Plan.Assist in the creation and update SOPs related to Department of Transportation (DOT) hazmat shipping programs within the Medical and Pharmaceutical Distribution business, as directed.Interact with vendors (product and packaging) to create package systems compliant with DOT regulations for hazardous materials shipments.Participate, as necessary in current IT project workshops as a SME relating to product quality data, hazardous materials shipping, storage programs, etc.Create and deliver training programs relating to QRA topics.Identify quality and regulatory related issues within current processes, investigate and provide recommendations.
BA, BS preferred or equivalent experience in related field2-4 years of experience preferred
Excellent verbal, written, computer, and interpersonal skills
Must be able to work independently and pro-actively.
Certification for the transportation of hazardous materials for ground, air and water shipments preferred
OSHA regulations related to 29 CFR 1910.1200 (Hazard Communication) preferred
Department of Transportation (DOT) regulations for transporting hazardous materials 49 CFR 100-185 preferred
FDA regulations for prescription drugs and medical devices (21 CFR) preferred
Environmental Protection Agencies (EPA) regulations for handling and disposing of hazardous materials 40 CFR 260-265 preferred
Knowledge of Distribution Operations processes Medical and Pharmaceutical preferred
SAP and Agile knowledge preferred
Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasksWorks on projects of moderate scope and complexityIdentifies possible solutions to a variety of technical problems and takes action to resolveApplies judgment within defined parametersReceives general guidance and may receive more detailed instruction on new projectsWork reviewed for sound reasoning and accuracy
What is expected of you and others at this level
Anticipated salary range: $63,700-$91,000
Bonus eligible: No
Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LT
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.