Quality Assurance Lead: GMP, Compliance & Training

Cardinal Health Canada Inc.; Indianapolis (IN); Hybrid; USD 81,000 - 104,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k savings plan

HSA

FSAs

Paid time off

Parental leave

Disability coverage

Wellness programs

Work-Life resources

Job summary

Cardinal Health, Inc. is seeking a Principal Specialist, Quality Assurance in Indianapolis to ensure quality standards and procedures are followed across manufacturing processes.

The role oversees quality monitoring, inspections, and assurance to ensure products meet regulatory specifications. You will collaborate with plant management to troubleshoot deficiencies, develop corrective actions, and ensure compliant release of finished products.

Qualifications

• Bachelor’s degree in related field, or equivalent work experience, preferred.
• Advanced Degree may be preferred; 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 and documentation and reporting requirements.
• Interact with manufacturing and service functions to establish quality standards for raw material, work in process, and finished products.
• Champion GMP compliance and EHS/Radiation Safety practices.
• Develop and lead GMP/GDP training of all employees.
• Provide corrective measures to eliminate quality problems and ensure timely resolution of quality events.
• Review and disposition incoming raw materials and components.

Skills

GMP compliance

FDA regulations

Quality systems

Education

Bachelor’s degree in related field

Advanced Degree may be preferred

Job description

Cardinal Health, Inc. is seeking a Principal Specialist, Quality Assurance in Indianapolis to ensure quality standards and procedures are followed across manufacturing processes.

The role oversees quality monitoring, inspections, and assurance to ensure products meet regulatory specifications. You will collaborate with plant management to troubleshoot deficiencies, develop corrective actions, and ensure compliant release of finished products.