Second-Shift Senior QA Specialist – GMP & Training Leader

Cardinal Health

Indianapolis (IN)

On-site

USD 82,000 - 105,000

Full time

4 days ago

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Benefits offered by this job

Medical coverage

Dental & Vision coverage

401k savings plan

Paid time off

HSA

FSAs

Disability coverage

Work-Life resources

Parental leave

Job summary

Cardinal Health seeks a Principal Specialist, Quality Assurance to develop and enforce quality policies and supervise GMP/GDP compliance on site in Indianapolis. You will oversee quality monitoring, train staff, and ensure products meet FDA/EU regulations.

This role requires a Bachelor's degree in a related field (Advanced degree preferred) and 4–8 years of experience. You will collaborate with manufacturing, review raw materials, and drive continuous improvement of the GMP Quality Management

Qualifications

Bachelor’s degree in related field, or equivalent work experience.
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 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.
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.