Senior QA Specialist - GMP/GDP Quality Leader (Second Shift)

Cardinal Health, Inc.; Legendary Hills (IN); Presencial; USD 82 000 - 105 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical coverage

Dental coverage

Vision coverage

HSA

401k

MyFlexPay

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Wellness programs

Resumo da oferta

Cardinal Health, Inc. is seeking a Principal Specialist, Quality Assurance for on-site duties in Indiana. The role focuses on ensuring quality standards, overseeing monitoring, and aligning production with GMP/GDP requirements.

You will lead QA activities, collaborate with plant management, and support regulatory compliance across FDA/EU guidelines. The position emphasizes GMP training, quality event oversight, and continuous improvement within a fast-paced manufacturing environment, requiring

Qualificações

• Bachelor’s degree in related field, or equivalent work experience, preferred.
• Advanced Degree may be preferred, depending on role.

Responsabilidades

• 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.

Formação académica

Bachelor’s degree or equivalent

Advanced degree preferred

Descrição da oferta de emprego

Cardinal Health, Inc. is seeking a Principal Specialist, Quality Assurance for on-site duties in Indiana. The role focuses on ensuring quality standards, overseeing monitoring, and aligning production with GMP/GDP requirements.

You will lead QA activities, collaborate with plant management, and support regulatory compliance across FDA/EU guidelines. The position emphasizes GMP training, quality event oversight, and continuous improvement within a fast-paced manufacturing environment, requiring