Job Description
What Quality Compliance 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 Compliance is responsible for the development and deployment of policies, procedures and programs designed to minimize risk, enable compliant business operations, products and services and drive uncompromised supply chain integrity.
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
May have one or more direct reports and/or oversight of a quality department within a different facility.
Responsibilitie
s
Responsible for the implementation and execution of the Cardinal Health Quality System
Supports 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.
Develops, implements and maintains standard operating procedures, programs and processes to ensure conformance with quality, regulatory and company requirements.
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.
Monitors Federal, State, and local regulatory activities in order to implement new Company procedures or update existing procedures to facilitate compliance.
Coordinate and manage QRA-related activities throughout the facility by
Investigating non-conformances with QRA policies and report to Corp QRA, vendors, business partners and other leadership groups, as necessary (FDA)
Documenting the event utilizing the current NCR/CAPA system
Investigating (or coordinating investigation) of customer complaints and providing response to Corp QRA or another designated group.
Overseeing compliance with established procedures
Facility POC for agency or internal QRA inspections
Overseeing facility training programs (FDA, DOT, etc.)
Facilitating temperature monitoring for all assigned storage locations as required by procedure
Reviewing monthly temperature records to ensure completion and accuracy
Coordinating calibration of temperature monitoring equipment; maintaining and verifying appropriate records are maintained.
Facilitating reporting and management of temperature excursions and other situations.
Coordinating annual security alarm tests and quarterly alarm tests for refrigerators and freezers
Coordinating with on-site Facilities team to develop and maintain a listing of equipment and systems that require a preventative maintenance program.
Ensuring documentation is complete and filed accordingly.
Overseeing facility process to ensure product is maintained and stored according to storage requirements, including temperature, protect from light, upright storage, cube, debris, out of location product, etc.
Coordinating with appropriate facility personnel any non-compliances with storage requirements
Developing and implementing corrective action plan to prevent recurrence.
Ensuring that the facility does not ship expired product
Periodically verifying that expired product is appropriately tagged and moved into quarantine areas as soon as possible after discovery
Ensuring there are designated product storage areas for all product status types (FCA, Quarantine, Hold, Discard, etc.).
Facilitating and/or organizing facility housekeeping program.
Facilitating pest control program at facility. Ensure monthly checks are complete and according to protocol and that required maintenance noted on monthly reports is addressed.
Maintaining or coordinating with local training coordinator, all employee training is up to date and training files on myLearning
Ensuring that a facility?s hazardous materials program meets current policy
Ensuring that hazardous materials are stored in appropriate locations in warehouse
Coordinating with Outbound Operations shipments of hazardous materials are being prepared correctly according to current policy
Ensuring that the facility?s cold-chain packing program meets current policy.
Monitoring and verifying site compliance with specified FCA, returns, and other QIC-related programs to ensure that on-site process meets QRA policy
Verifying documentation to determine compliance with Good Documentation Practices (GDP) and current policy
Verifying site compliance with any stipulated DSCSA and vendor verification requirements
Qualifications
4-8 years of experience, preferred
Bachelor's degree in related field, or equivalent work experience, preferred
Location: Will support the Columbus-Ohio Valley Distribution Center as well travel to our Cincinatti location as needed
Anticipated salary range:
$79,300 - $113,800
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:
4/12/2025 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 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.
To read and review this privacy notice click
here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Compliance is responsible for the development and deployment of policies, procedures and programs designed to minimize risk, enable compliant business operations, products and services and drive uncompromised supply chain integrity.
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
May have one or more direct reports and/or oversight of a quality department within a different facility.
Responsibilitie
s
Responsible for the implementation and execution of the Cardinal Health Quality System
Supports 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.
Develops, implements and maintains standard operating procedures, programs and processes to ensure conformance with quality, regulatory and company requirements.
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.
Monitors Federal, State, and local regulatory activities in order to implement new Company procedures or update existing procedures to facilitate compliance.
Coordinate and manage QRA-related activities throughout the facility by
Investigating non-conformances with QRA policies and report to Corp QRA, vendors, business partners and other leadership groups, as necessary (FDA)
Documenting the event utilizing the current NCR/CAPA system
Investigating (or coordinating investigation) of customer complaints and providing response to Corp QRA or another designated group.
Overseeing compliance with established procedures
Facility POC for agency or internal QRA inspections
Overseeing facility training programs (FDA, DOT, etc.)
Facilitating temperature monitoring for all assigned storage locations as required by procedure
Reviewing monthly temperature records to ensure completion and accuracy
Coordinating calibration of temperature monitoring equipment; maintaining and verifying appropriate records are maintained.
Facilitating reporting and management of temperature excursions and other situations.
Coordinating annual security alarm tests and quarterly alarm tests for refrigerators and freezers
Coordinating with on-site Facilities team to develop and maintain a listing of equipment and systems that require a preventative maintenance program.
Ensuring documentation is complete and filed accordingly.
Overseeing facility process to ensure product is maintained and stored according to storage requirements, including temperature, protect from light, upright storage, cube, debris, out of location product, etc.
Coordinating with appropriate facility personnel any non-compliances with storage requirements
Developing and implementing corrective action plan to prevent recurrence.
Ensuring that the facility does not ship expired product
Periodically verifying that expired product is appropriately tagged and moved into quarantine areas as soon as possible after discovery
Ensuring there are designated product storage areas for all product status types (FCA, Quarantine, Hold, Discard, etc.).
Facilitating and/or organizing facility housekeeping program.
Facilitating pest control program at facility. Ensure monthly checks are complete and according to protocol and that required maintenance noted on monthly reports is addressed.
Maintaining or coordinating with local training coordinator, all employee training is up to date and training files on myLearning
Ensuring that a facility?s hazardous materials program meets current policy
Ensuring that hazardous materials are stored in appropriate locations in warehouse
Coordinating with Outbound Operations shipments of hazardous materials are being prepared correctly according to current policy
Ensuring that the facility?s cold-chain packing program meets current policy.
Monitoring and verifying site compliance with specified FCA, returns, and other QIC-related programs to ensure that on-site process meets QRA policy
Verifying documentation to determine compliance with Good Documentation Practices (GDP) and current policy
Verifying site compliance with any stipulated DSCSA and vendor verification requirements
Qualifications
4-8 years of experience, preferred
Bachelor's degree in related field, or equivalent work experience, preferred
Location: Will support the Columbus-Ohio Valley Distribution Center as well travel to our Cincinatti location as needed
Anticipated salary range:
$79,300 - $113,800
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:
4/12/2025 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 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.
To read and review this privacy notice click
here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)
Key skill Required
- Quality Management
- Accounts
- Business Operations
- Calibration
- Compliance
- Comprehensive
- Consistent
- Corrective Action Plan
- Development
- Documentation
- Documentation Practices
- Facilitate
- Guidance
- Implementation
- Inclusive
- Investigation
- Leadership
- Maintenance
- Management
- Management Systems
- Meeting Objectives
- Orientation
- Pay Equity
- Performance Improvement
- Pest Control
- Policies and Procedures
- Regulatory Standards
- Reporting
- Security
- Supply Chain
- Thought Leadership
- Training
- Values Diversity
