Principal Specialist, Quality Assurance

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

• Inspects and samples of product throughout the manufacturing process.
• Establish and maintain quality control procedures.
• Aid 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.
• Aids 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.
• 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.
• Able 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.
• Performs other job duties as assigned.

Qualifications 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.
• Contributes 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.
• Acts as a mentor to less experienced colleagues.

Pay and Benefits

Anticipated salary range: $79,700 - $113,800
Bonus eligible: No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vision coverage
Paid time off plan
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