Cardinal Health
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Principal Specialist, Quality Assurance
role at
Cardinal Health .
Schedule
Weekend Shift – Anticipated Friday through Monday
Potential to work 1st shift to cover PTO of other analysts
Initial training for this role will be provided on 1st shift
What Quality Assurance Contributes To Cardinal Health Quality develops and implements policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. The Quality Assurance team oversees production and manufacturing activities, provides training to personnel, and educates business leaders on quality practices. They ensure that all products and services are properly reviewed for quality and documented.
Principal Specialist – Quality Assurance 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.
Assist 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.
Ensure quality events are complete, 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.
Understand technical/release product issues and evaluate their potential impact on product quality and compliance.
Provide ideas for continuous improvement of the GMP Quality Management System.
Escalate complex issues to management in a timely manner.
Prioritize and ensure work is delivered efficiently.
Perform other job duties as assigned.
Qualifications
Bachelor’s degree in a related field, or equivalent work experience. Advanced Degree may be preferred.
4–8 years’ experience in a related field.
What is expected of you and others at this level
Apply comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
Contribute to the development of policies and procedures.
Work on complex projects of large scope.
Develop technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives.
Complete work independently and receive general guidance on new projects.
Work reviewed for purpose of meeting objectives.
May act as a mentor to less experienced colleagues.
Anticipated Salary Range $79,700 - $113,800
Bonus Eligible No
Benefits
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401(k) savings plan
Access to wages before payday 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: 2/1/2025. If interested in this opportunity, please submit your 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 candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
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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Principal Specialist, Quality Assurance
role at
Cardinal Health .
Schedule
Weekend Shift – Anticipated Friday through Monday
Potential to work 1st shift to cover PTO of other analysts
Initial training for this role will be provided on 1st shift
What Quality Assurance Contributes To Cardinal Health Quality develops and implements policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. The Quality Assurance team oversees production and manufacturing activities, provides training to personnel, and educates business leaders on quality practices. They ensure that all products and services are properly reviewed for quality and documented.
Principal Specialist – Quality Assurance 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.
Assist 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.
Ensure quality events are complete, 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.
Understand technical/release product issues and evaluate their potential impact on product quality and compliance.
Provide ideas for continuous improvement of the GMP Quality Management System.
Escalate complex issues to management in a timely manner.
Prioritize and ensure work is delivered efficiently.
Perform other job duties as assigned.
Qualifications
Bachelor’s degree in a related field, or equivalent work experience. Advanced Degree may be preferred.
4–8 years’ experience in a related field.
What is expected of you and others at this level
Apply comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
Contribute to the development of policies and procedures.
Work on complex projects of large scope.
Develop technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives.
Complete work independently and receive general guidance on new projects.
Work reviewed for purpose of meeting objectives.
May act as a mentor to less experienced colleagues.
Anticipated Salary Range $79,700 - $113,800
Bonus Eligible No
Benefits
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401(k) savings plan
Access to wages before payday 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: 2/1/2025. If interested in this opportunity, please submit your 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 candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
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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