Principal Specialist, Quality Assurance

Cardinal Health; Indianapolis (IN); On-site; USD 81,000 - 104,000; Full time

Benefits offered by this job

Medical coverage

Paid time off

Health savings account

401k savings plan

MyFlexPay access to wages

FSAs

Disability coverage

Work-Life resources

Parental leave

Wellness programs

Job summary

Cardinal Health seeks a Principal Specialist in Quality Assurance to review customer threshold activity requests for controlled substances, assess risk, and support regulatory documentation. This role assists the Manager in data entry and filing, ensuring consistent application of threshold methodologies across the organization.

Key responsibilities include supporting FDA/regulatory activities, auditing for compliance, and mentoring staff. Salary range is anticipated and bonus eligibility is No.

Qualifications

• Bachelor's degree in related field, or equivalent work experience, preferred.
• 4-8 years of experience, preferred.
• Possess an understanding of cGMP/compliance requirements for cosmetic or pharmaceutical products.
• CQA preferred

Responsibilities

• Assists Quality Management with FDA and other regulatory agency activities.
• Document and report quality and compliance issues to QA management as necessary.
• Proposes and/or implements audit program enhancements.
• Audits groups to ensure consistency in the application of practices and regulatory compliance with established methodologies.
• Completes work independently; receives general guidance on new projects.
• Drafts memos and other regulatory related documents to support risk management activities.
• May act as a mentor to less experienced colleagues.
• Coordinates on site visits to ensure successful completion of investigations ensuring necessary staff will be on site at the time of the visit.
• Prepares Cardinal Health communications relating to site visits and related investigatory activity.
• Prepares investigators for site visits through the collection and distribution of investigation materials.
• Canvases order volume reports and publicly available data to identify suspicious activity and determine sites of interests.
• Reviews threshold events triggered by customer orders nearing or exceeding predetermined thresholds.
• Approves and implements threshold adjustments and requests within certain controlled substance levels.
• Escalates threshold events for management review and approval, as needed.
• Ensures compliance with established memorandums of agreement.
• Drafts memos and other regulatory related documents to support risk management activities.

Skills

4-8 years experience

cGMP knowledge

Regulatory compliance

Quality assurance

Education

Bachelor's degree in related field

Job description

What Quality Assurance 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 Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Job Summary

The Principal Specialist, Quality Assurance is responsible for reviewing all customer threshold activity requests for controlled substances in compliance with set standards. This job reviews inbound requests, assesses them for risk and escalates according the standard operating procedures. The Principal Specialist, Quality Assurance assists the Manager, Regulatory Management in data entry activity and documentation drafting/filing. This job ensures the consistent application of set threshold methodologies across the organization.

Responsibilities

• Assists Quality Management with FDA and other regulatory agency activities.
• Document and report quality and compliance issues to QA management as necessary.
• Proposes and/or implements audit program enhancements.
• Audits groups to ensure consistency in the application of practices and regulatory compliance with established methodologies.
• Completes work independently; receives general guidance on new projects.
• Drafts memos and other regulatory related documents to support risk management activities.
• May act as a mentor to less experienced colleagues.
• Coordinates on site visits to ensure successful completion of investigations ensuring necessary staff will be on site at the time of the visit.
• Prepares Cardinal Health communications relating to site visits and related investigatory activity.
• Prepares investigators for site visits through the collection and distribution of investigation materials.
• Canvases order volume reports and publicly available data to identify suspicious activity and determine sites of interests.
• Reviews threshold events triggered by customer orders nearing or exceeding predetermined thresholds.
• Approves and implements threshold adjustments and requests within certain controlled substance levels.
• Escalates threshold events for management review and approval, as needed.
• Ensures compliance with established memorandums of agreement.
• Drafts memos and other regulatory related documents to support risk management activities.

Qualifications

• Bachelor's degree in related field, or equivalent work experience, preferred
• 4-8 years of experience, preferred
• Possess an understanding of cGMP/compliance requirements for cosmetic or pharmaceutical products.
• CQA preferred

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

Anticipated salary range: $80,900.00-$103,950.00

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 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.