Senior Specialist, Quality Assurance

Job Summary The quality assurance specialist (QAS) performs all quality review and approval/release decisions at an FDA-regulated drug manufacturing facility. The facility manufactures three sterile liquid injection drugs, FDG, NaF and Vizamyl, that are used for Positron Emission Tomography (PET) scans. Responsibilities Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls. Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager RQM. Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP). Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities. Engages and collaborates with operations department to drive quality system and CGMP requirements. Performs product release activities per CGMP requirements. Monitors CAPA in investigations and closes when completed or escalates (if necessary). Performs aseptic review of the site with operations and documents results. Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification. Schedule Site production hours are Monday through Friday from 1am-12pm. Rotating schedule (1am-9am and 4am-12pm). Occasional weekends may be required. Location Onsite in Columbus, OH. Qualifications 2-4 years of experience Preferred: bachelor's degree in related field, or equivalent work experience Proficiency with MS Excel and MS Word Interpersonal skills Attention to detail Preferred: prior experience working nightshift Preferred: prior experience maintaining a filing system Preferred: project management Preferred: prior experience in a cGMP environment What is expected of you and others at this level Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks. Works on projects of moderate scope and complexity. Identifies possible solutions to a variety of technical problems and takes action to resolve. Applies judgment within defined parameters. Receives general guidance and may receive more detailed instruction on new projects. Work reviewed for sound reasoning and accuracy. Anticipated salary range $66,500 - $95,000 Bonus eligible: No Benefits 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 10/24/2026 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. #J-18808-Ljbffr