Principal Specialist, Quality Control - Incoming Materials

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

Application window anticipated to close: 03/05/2025 *if interested in opportunity, please submit application as soon as possible.

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.

What a Principal Specialist, Quality Control (Incoming Materials) contributes to Cardinal Health

• Reports to Manager, Quality Control (Incoming Materials).
• Quality control is responsible for the analysis or inspection of products or materials for compliance with specifications and standards.
• Demonstrates detail-oriented attention in all facets of responsibilities.
• Performs visual inspection, dimensional measurement, physical characterization and analytical evaluation or test of products or processes.
• Demonstrates knowledge of testing methods, product usage, and applicable regulations and standards.
• Adheres to established policies and procedures.
• Establishes test methodology.
• Serves as a technical mentor and trainer to others on SOPs and quality guidelines.

Responsibilities

• Insures timely and thorough inspections and analysis of incoming, raw and GMP printed materials.
• Serves as a technical mentor and trainer to personnel working in the QC Incoming Materials section.
• May lead and facilitate the qualification of applicable analytical instrumentation.
• Performs investigations, deviations, change controls and CAPAs.
• Serves as a subject matter expert (SME) for the inspection and analysis of incoming, raw and GMP printed materials
• Authors and optimizes standard operating procedures, analytical method worksheets, forms and other documents as necessary and applicable.
• Performs special projects or tasks as necessary based on skill set and/or development goals and business needs.
• Performs other job duties as assigned.

Qualifications

• Bachelor’s degree or previous work experience in a similar role or related field, such as materials management or warehouse.
• 4+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated
• industry (Pharmaceutical or Medical Device).
• Has experience in authoring a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
• Must work well with others and understand how to be successful in a Team environment.
• Must be detail oriented, organized, able to multi­task, a self­starter, and self­motivated.
• Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
• Demonstrated success in collaborating with people and working on a team.
• Strong communications skills.

What is expected of you and others at this level

• This role serves as a technical lead of Quality Control regarding incoming GMP material inspection and physical characterization testing and performs investigations of non-conforming materials as necessary.
• This role serves as a lead collaborator on behalf of Quality Control with multiple different Cardinal Health departments at this plant site to coordinate and facilitate the packaging and shipment of materials to external service vendors for testing that cannot be performed on site.
• This position also serves as the liaison between Quality Control and external service vendors and is responsible for scheduling testing and timely receipt of reported results from external service vendors for the purpose of releasing incoming GMP material for use in the manufacture of product(s) at this site.
• Has in-depth knowledge of work processes and tools within own area and can function as Subject Matter Expert (SME) for processes, tools, and equipment.
• Role models Cardinal Health's high ethical standards and code of conduct.
• Builds confidence and respect of others through a positive and energizing style.
• Is aware of internal/external business issues and adapts work priorities in own area.
• Actively builds relationships across functions/businesses th