Quality Assurance Principal: GMP & Compliance Lead

Regulatory Jobs; Indianapolis (IN); Sur place; USD 82 000 - 105 000; Plein temps

Avantages offerts par ce poste

Medical, dental and vision coverage

Paid time off (Untracked)

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Résumé du poste

Cardinal Health is seeking a Principal Specialist, Quality Assurance to oversee and ensure high-quality products across manufacturing and testing. This role reports to the Manager, Quality Assurance and drives quality monitoring, policy enforcement and training to ensure compliance with regulatory standards.

The position is on-site for a second shift, requiring collaboration with plant teams and timely escalation of complex quality issues.

Qualifications

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

Responsabilités

• 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.

Formation

Bachelor’s degree in related field

Advanced degree preferred

Description du poste

Cardinal Health is seeking a Principal Specialist, Quality Assurance to oversee and ensure high-quality products across manufacturing and testing. This role reports to the Manager, Quality Assurance and drives quality monitoring, policy enforcement and training to ensure compliance with regulatory standards.

The position is on-site for a second shift, requiring collaboration with plant teams and timely escalation of complex quality issues.