Principal Specialist, Quality Assurance

What Quality Assurance contributes to Cardinal Health

Quality Assurance at Cardinal Health is dedicated to developing and implementing robust quality policies procedures and processes to ensure that all products and services consistently meet regulatory standards and specifications. We are committed to establishing and maintaining a compliant and cost-effective quality system that guarantees the reliability safety and effectiveness of our offerings. This involves providing expert oversight of production/ manufacturing activities delivering essential training to operational and quality control personnel and educating business leaders on critical Quality policies and procedures. Our ultimate goal is to ensure that all products and services undergo thorough quality review and are meticulously documented.

Job Summary

The Principal Specialist Quality Assurance is a highly experienced individual contributor who applies advanced knowledge of quality assurance concepts and technical capabilities to drive uncompromised laboratory integrity and minimize risks. This role is pivotal in leading the improvement of quality processes and systems. The Principal Specialist collaborates cross-functionally to develop innovative solutions to complex quality issues and independently leads significant quality audits. When developing new standard operating procedures or revising existing practices the Principal Specialist is responsible for ensuring organizational alignment and monitoring adherence. This role requires a proactive leader who can step up to provide guidance and direction in the absence of the manager ensuring continuity and effective decision-making within the Quality Assurance function.

Responsibilities

• Process Improvement Leadership: Proactively identifies opportunities and leads initiatives for the continuous improvement of Quality policies programs and processes across the organization ensuring they are compliant efficient and effective.
• Leadership in Managers Absence: Acts as a key leader and decision-maker when the manager is unavailable providing guidance resolving critical issues and ensuring the smooth continuation of Quality Assurance operations.
• Expert Guidance & Mentorship: Serves as a subject matter expert providing advanced guidance and mentorship to less experienced Quality Assurance and Quality Control Specialists fostering a culture of excellence and continuous learning.
• Policy Development & Implementation: Leads the development implementation and continuous enhancement of internal Quality policies and programs ensuring alignment with external reporting requirements for products and operations.
• Cross-functional Collaboration: Leads complex cross-functional projects to identify root causes of significant quality issues educates stakeholders on quality requirements and develops sustainable solutions to minimize future risks.
• SOP Management: Drives the update and revision of standard operating procedures in response to product changes regulatory developments and resolutions to significant quality issues setting precedents for best practices.
• Regulatory Liaison: Serves as a primary liaison with regulators responding to regulatory queries and compiling necessary information during regulatory audits.
• Quality Audits: Leads quality audits to ensure compliance with standard operating procedures reporting findings to Operations teams and providing expert guidance on process improvements.
• Laboratory Quality Oversight: Oversees the review and approval of QC data validation of analytical methods and laboratory metrics to ensure accuracy and precision. Leads out-of-specification (OOS) investigations planned deviations nonconformances and corrective and preventive actions (CAPA).
• Quality Management System (QMS) Leadership: Leads and maintains the laboratory quality management system ensuring rigorous adherence to ISO/IEC 17025 GLP (Good Laboratory Practice) GMP (Good Manufacturing Practice) or EPA/CLIA standards.

Qualifications

• Bachelors degree in chemistry Biochemistry or a related scientific field is required. An advanced degree is a plus.
• A minimum of 4-8 years of progressive experience in a Quality Assurance role within a GxP laboratory environment demonstrating increasing levels of responsibility and technical expertise.
• Proven experience leading projects initiatives or significant quality improvement efforts.
• Demonstrated ability to act autonomously and make critical decisions in complex situations.

What is Expected of You and Others at This Level

• Operates as a highly influential individual contributor providing expert guidance and technical leadership without direct supervisory responsibilities.
• Takes initiative and ownership stepping up to lead critical functions and decision-making in the absence of management.
• Leads the development and implementation of policies and procedures driving continuous improvement to achieve strategic goals.
• Decisions have a significant impact on work processes outcomes and customer satisfaction often influencing long-term quality strategy.
• Interacts and influences peers customers suppliers and senior management gaining consensus and driving alignment on complex quality issues.
• Acts as a mentor and coach to less experienced team members sharing knowledge and best practices.
• Champions Quality GMP compliance and EHS/Radiation Safety practices actively partnering with plant management to troubleshoot deficiencies and implement corrective measures.

Anticipated salary range:$90600 - $116460

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:5/1/2026 *if interested in opportunity please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including but not limited to a candidates geographical location relevant education experience and skills and an evaluation of internal pay equity.

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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.

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