Quality Assurance Specialist jobs in Carrollton, TX

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.

Job Summary

The Principal Specialist, Quality Assurance is responsible for reviewing all inbound requests, assesses them for risk and escalates according the standard operating procedures. The Principal Specialist, Quality Assurance assists the Manager, Quality Management in data entry activity and documentation drafting/filing. This job ensures the consistent application of set quality methodologies across the organization.

Responsibilities

• Coordinates on site visits to ensure successful completion of investigations ensuring necessary staff will be on site at the time of the visit.
• Partners with the analytics team to identify opportunities for improvement.
• Prepares Cardinal Health communications relating to site visits and related investigatory activity.
• Prepares investigators for site visits through the collection and distribution of investigation materials.
• Escalates quality events for management review and approval, as needed.
• Audits groups to ensure consistency in the application of practices and regulatory compliance with established methodologies.
• Ensures compliance with established memorandums of agreement.
• Drafts memos and other regulatory related documents to support risk management activities.
• Manage Corrective Action (CAPA) investigations to ensure completion and accuracy.
• Conducts quality training and manages training curriculum and reporting.
• Support and facilitate licensing activities.

Qualifications

• 4-8 years of experience, preferred
• Bachelor's degree in related field, or equivalent work experience, preferred
• ISO 9001:2015 & 14001:2015 experience, preferred
• Lean Six Sigma experience, preferred

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

Anticipated salary range: $78,500 - $112,100

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 4/22/2024 *if interested in opportunity, please submit application as soon as possible.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. 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.