Principal Specialist, Quality Control (Chemistry) – Incoming Materials

Job description

At Cardinal Health, we’re developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities. What a Principal Specialist, Quality Control (Chemistry) – Incoming Materials contributes to Cardinal Health Quality Control is responsible for the analysis and inspection of products or processes for compliance with specifications and standards. Reports to Supervisor, Quality Control Incoming Materials (Chemistry). Demonstrates detail-oriented attention in all facets of responsibilities. Performs visual inspection, dimensional measurement, physical characterization and analytical evaluation or test of products and processes. Demonstrates knowledge of testing methods, product usage, and applicable regulations and standards. Adheres to established policies and procedures. Establishes test methodology and may contribute to the development of policies and procedures. Serves as a technical mentor and trainer to others on SOPs and quality guidelines. What is expected of you and others at this level 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. Serves as a lead collaborator on behalf of Quality Control with multiple different Cardinal Health departments to coordinate and facilitate the packaging and shipment of materials to external service vendors for testing that cannot be performed on site. Has in-depth knowledge of work processes and tools within own area and can function as a Subject Matter Expert (SME) for processes, tools, and equipment. Exhibits Cardinal Health's high ethical standards and code of conduct. 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). Builds confidence and respect of others through a positive and energizing style. Possesses in-depth knowledge of work processes and tools within own area and can function as a Subject Matter Expert (SME) for processes, tools, and equipment. Gain awareness of other departments at site. Seek to understand the functions of those departments and the points of interaction between QC and your role. Exhibit professional conduct, respect for others, and understands how to be successful in a team environment. Is detail oriented, organized, had the ability to multi-task, and is self-motivated. Is aware of internal/external business issues and adapts work priorities in own area. Demonstrates strong communication skills. Effectively listens to and explains difficult issues to reach shared understanding and build alignment. Has the ability to act calmly and patiently when working under pressure and/conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives. Actively builds relationships across functions/businesses that bring value to the company, encouraging the participation and perspectives of all team members, regardless of background. Responsibilities Works with multiple departments 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. Provide material to the Warehouse teams for shipment to outsource testing facilities. Work directly with outsource testing labs to ensure timely completion of testing. Serve 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 (SOPs), laboratory testing forms, and other documents as necessary and applicable. Performs special projects or tasks as necessary based on skill set and/or developmental goals and business needs. Ensures timely and thorough inspections and analysis of Drug Substance, In-Process, and Drug Product samples. Executes method verification, validation, and/or transfer protocols. Performs stability testing in alignment with stability protocol(s) at the prescribed cadence. Performs visual assessment and analytical evaluation or test of products/processes. Established test methodology and adheres to established policies and procedures. 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 also be vendor-executed). Performs other job duties as assigned. Qualifications Bachelor’s degree or previous work experience in a similar role or related field, Chemistry or Biology preferred. 4+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) with SAP experience preferred. Has experience in authoring a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations. Proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills. Physical/ Mental Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; balance; stoop, kneel, crouch or crawl. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus. Work Environment The primary work environment consists of a professional office environment within a radiopharmaceutical manufacturing facility, the materials warehouse as well as the laboratory setting. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate. Anticipated salary range: $80,900.00-$103,950.00 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: 10/13/2026 *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. 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