Senior Quality Assurance Specialist — GMP & Compliance

Cardinal Health, Inc.; Indianapolis (IN); On-site; USD 82,000 - 105,000; Full time

Benefits offered by this job

Medical, dental and vision

Paid time off

Health Savings Account

401k plan

myFlexPay

FSAs

Disability coverage

Work-Life resources

Parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Principal Specialist, Quality Assurance to oversee quality standards and GMP/GDP compliance across manufacturing processes. The role requires inspecting products, implementing quality control procedures, and leading training to ensure products meet regulatory specifications.

You will partner with plant management to troubleshoot quality deficiencies, coordinate testing, and ensure timely release of final products under FDA/EU regulations.

Qualifications

• Bachelor’s degree in related field, or equivalent work experience.
• 4-8 years’ experience in related field, preferred

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.
• Assists 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.

Skills

Quality Assurance

GMP Compliance

Quality Training

Inspection

Education

Bachelor’s degree or equivalent

Advanced degree preferred

Job description

Cardinal Health is seeking a Principal Specialist, Quality Assurance to oversee quality standards and GMP/GDP compliance across manufacturing processes. The role requires inspecting products, implementing quality control procedures, and leading training to ensure products meet regulatory specifications.

You will partner with plant management to troubleshoot quality deficiencies, coordinate testing, and ensure timely release of final products under FDA/EU regulations.