Principal Specialist, Quality Assurance (2nd Shift)

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

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.

Skills

Quality Assurance

GMP compliance

Quality monitoring

Inspection

Process improvement

Education

Bachelor's degree in related field

Advanced Degree preferred

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. What a Principal Specialist, Quality Assurance contributes to Cardinal Health Reports to Manager, Quality Assurance. QA Principal Specialist is responsible for ensuring quality standards and procedures are followed and will oversee quality monitoring and assurance to ensure that all products manufactured are of the highest quality possible. Inspection and quality assurance activities to meet specifications and quality standards for variety of in-process and finished products. Authorized to inspect products to ensure the required quality standards are met.

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.
• Required to have visual acuity and color perception
• Near-vision performance should be the equivalent of 20/20 with no impairment of color vision or correctable to 20/20 vision with the use of corrective lenses
• Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements.
• Responsible for approval of minor Quality Events.
• Ability to network across business and functional units to achieve positive outcomes.
• Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting.
• In that context, has the knowledge of the production process of the product.
• Understands technical/release product issues and evaluate their potential impact on product quality and compliance.
• Provides ideas for continuous improvement of the GMP Quality Management System.
• Escalates complex issues to management in a timely manner.

Schedule

This will be a second shift position on site

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

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.

Salary and Benefits

Anticipated salary range: $82,100-$105,480 Bonus eligible: No

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.

Benefits

• Medical, dental and vision coverage
• Paid time off (Untracked)
• 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

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.

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.