Quality Assurance Supervisor

Cardinal Health•Jacksonville, FL

About The Position

What Quality Assurance contributes to Cardinal Health Quality Assurance is responsible for developing and implementing a compliant and cost-effective quality system that ensures 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. Overview of Role: Demonstrates knowledge of regulatory requirements and utilizes depth and breadth of experience to assess regulatory changes, risk and business impact. Responsible for the local oversight of the Supplemental Purchasing Program at the Jacksonville Medical facility from a QRA perspective and supervise team of Quality Assurance (QA) specialists. Provide Quality support to Jacksonville Medical Distribution facility and the Jacksonville Cardinal Health At Home Solutions facility (support two buildings). Responsible for the implementation and execution of the Cardinal Health Quality System of one or more Medical Distribution facilities (including Replenishment Centers, AeroMed, Cardinal Health At Home and/or Cardinal Health Canada). Directs efforts to assess the implementation of Quality Management Systems (QMS) to drive performance improvement and enhance supply chain integrity while preserving and optimizing system efficiency. Applies thought leadership and expertise to assess, evaluate, manage, mitigate and balance risk and enhance business performance. Provides ongoing guidance and direction to operations personnel regarding regulatory and quality matters. Serves as liaison with local, state and federal government agencies including accreditation agencies (CHAP). Experience with the multiple regulatory entities (21 CFR Part 205, 820, DOT 49 CFR , etc.; Health Canada, VAWD, etc.) is desirable. Assists with licensure requests to include research on regulations, providing sales reports, or answering general licensing questions. Expectations: Understanding of concepts, principles, and technical capabilities to participate in a wide variety of projects. Participates in the development of policies and procedures to achieve specific goals. Works closely with Operations Leadership, Lean Six Sigma (LSS) and other functional groups to initiate and drive change. Recommends new practices, processes, metrics, or models related to quality and regulatory programs. Leads non-conformance and CAPA investigations using Root Cause Analysis techniques and leading to sustainable corrective actions. Provides solutions which may set precedent. Independently determines method for completing new projects with general guidance. Drive culture change and enhancement within facilities. Lead or participate in international QMS projects, as directed.

Requirements

Bachelors in related field, or equivalent work experience, preferred.
4+ years’ experience in related field, preferred.
Previous auditing experience and CQA preferred.
Coordinate and supervise the daily activities of operations, or business support staff.
Administer and execute policies and procedures.
Ensure employees operate within guidelines.
Realize decisions have a direct impact on work unit operations and customers.
Interact with subordinates, customers and peer groups at various management levels.
Understand interactions normally involve information exchange and basic problem resolution.

Responsibilities

Coordinate and manage QRA-related activities throughout the facility to:
Investigate non-conformances with QRA policies and report to Corp QRA, vendors, business partners and other leadership groups, as necessary (FDA).
Document the event utilizing the current NCR/CAPA system.
Investigate (or coordinate investigation) of customer complaints and provide response to Corp QRA or another designated group.
Oversee compliance with established procedures.
Function as the facility POC for agency or internal QRA inspections.
Oversee facility training programs (FDA, DOT, etc.)