**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 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 Control is responsible for the analysis or inspection of materials, components, products or processes for compliance with specifications and standards. **_Responsibilities_** + Works with Warehouse/Production to ensure timely and thorough inspections and analysis of incoming, raw and GMP printed materials. + Creates specifications by thoroughly investigating incoming materials and associated requirements: Certificates, storage condition, expiration date, sampling quantity, sampling requirements, etc. + Creates inspection plans, material inspection characteristics, and assigns them to materials in SAP + Package and provide material to the warehouse team for shipment to outsource testing facilities + Works directly with Outsource testing labs to ensure timely completion of testing + Serves as a technical mentor and trainer to personnel working in the QC Incoming Materials section or on incoming material inspections. + 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. + Ensures timely and thorough inspections and analysis of Drug Substance, In-Process and Drug Product samples. + Execute method verification, validation and/or transfer protocols. + Perform stability testing in alignment with stability protocol(s) at the prescribed cadence. + Performs visual assessment and analytical evaluation or test of products or processes. + Adheres to established policies and procedures. + Establishes test methodology. + May train others on SOPs, PROTOCOLs, instruments and quality guidelines. + May execute analytical equipment qualification protocols or computer system validation including but not limited to, installation qualification, operational qualification, and performance qualification. These may be vendor-executed. **_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 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_** + 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 _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _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/Affirmative_ _Action 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._ _To read and review this privacy notice click_ here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)