Specialist, Quality Compliance

Cardinal Health; Annapolis (MD); Remote; USD 38,000 - 48,000; Full time

Benefits offered by this job

Medical, dental, vision

Paid time off

HSA

401k

MyFlexPay

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Wellness programs

Job summary

Cardinal Health is seeking a Specialist, Quality Compliance to support development and deployment of policies and programs that minimize risk and ensure regulatory compliance across the supply chain. This role involves working under guidance on complex projects to build knowledge and competence in quality and compliance activities.

The position emphasizes GDP, data integrity, and collaboration with senior team members on regulatory submissions and inspections.

Qualifications

• 0-2 years of experience, preferred
• Bachelor's degree in related field, or equivalent work experience, preferred

Responsibilities

• Supports field action activities by preparing, compiling, and coordinating required regulatory reports and submissions for internal review and approval.
• Supports implementation of quality and compliance programs by monitoring adherence to established procedures, policies, and applicable regulatory requirements, and providing guidance to internal stakeholders as needed.
• Collects, analyzes, and summarizes quality and compliance data to support regulatory inquiries, inspections, management review activities, and continuous improvement initiatives.
• Handles and ensures quality of documentation (control, retention, and archival) to support field action activities.
• Promotes and supports adherence to Good Documentation Practices (GDP) and data integrity requirements across quality and compliance activities.
• Assist in the preparation for and execution of regulatory inspections and audits.
• Partners with senior team members on regulatory submissions, compliance activities, process improvements, and investigations to develop knowledge and process of applicable regulations and internal quality requirements.

Education

Bachelor's degree or equivalent

Job description

Country-wide Remote

US-Nationwide-FIELD

Full time

20189410

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.

Job Summary

The Specialist, Quality Compliance supports 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. The Specialist frequently seeks guidance from more experienced senior team members and assists on more complex projects to develop advanced knowledge and technical capabilities.

Responsibilities

• Supports field action activities by preparing, compiling, and coordinating required regulatory reports and submissions for internal review and approval.

• Supports implementation of quality and compliance programs by monitoring adherence to established procedures, policies, and applicable regulatory requirements, and providing guidance to internal stakeholders as needed.

• Collects, analyzes, and summarizes quality and compliance data to support regulatory inquiries, inspections, management review activities, and continuous improvement initiatives.

• Handles and ensures quality of documentation (control, retention, and archival) to support field action activities.

• Promotes and supports adherence to Good Documentation Practices (GDP) and data integrity requirements across quality and compliance activities.

• Assist in the preparation for and execution of regulatory inspections and audits.

• Partners with senior team members on regulatory submissions, compliance activities, process improvements, and investigations to develop knowledge and process of applicable regulations and internal quality requirements.

Qualifications

• 0-2 years of experience, preferred

• Bachelor's degree in related field, or equivalent work experience, preferred

What is expected of you and others at this level

• Applies basic concepts, principles and technical capabilities to perform routine tasks

• Works on projects of limited scope and complexity

• Follows established procedures to resolve readily identifiable technical problems

• Works under direct supervision and receives detailed instructions

• Develops competence by performing structured work assignments

Anticipated hourly range: $27.30 per hour - $35.01 per hour

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

The hourly 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.

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 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)

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities.

We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care.

With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges - now, and in the future.

View Cardinal Health on YouTube (http://youtube.com/user/CardinalHealth)