Senior Specialist, Quality Assurance

Job Summary Quality Assurance Specialist (QAS) performs all quality review and approval/release decisions at an FDA‑regulated drug manufacturing facility that produces three sterile liquid injection drugs—FDG, NaF, and Vizamyl—used for Positron Emission Tomography (PET) scans. The role ensures compliance with regulatory standards and internal quality systems, oversees production and manufacturing activities, and educates business leaders on quality policies. Responsibilities Handle CGMP documentation review related to product release, facilities, equipment, material and laboratory controls, packaging and labeling, and production & process controls. Establish and report metrics related to products and processes as directed by the Regional Quality Manager (RQM). Ensure the site manufactures products in accordance with 21CFR212 (CGMP). Maintain quality of documentation (control, retention, and archival) to support CGMP activities. Collaborate with operations to drive quality system and CGMP requirements. Perform product release activities per CGMP requirements. Monitor CAPA investigations, close when completed, or escalates as necessary. Conduct aseptic site reviews with operations and document results. Report quality system issues to the RQM and other stakeholders, including timely escalation of discrepancies. Schedule & Location Site production hours are Monday through Friday from 1am‑12pm. Rotating schedule (1am‑9am and 4am‑12pm). Occasional weekends may be required. Onsite in Columbus, OH. Qualifications 2–4 years of experience in a cGMP environment (preferred). Bachelor's degree in a related field or equivalent work experience (preferred). Proficiency with MSExcel and MSWord. Strong interpersonal skills and attention to detail. Prior experience working night shift (preferred). Prior experience maintaining a filing system (preferred). Project management experience (preferred). Salary Range Anticipated salary range: $66,500 – $95,000. Bonus eligible: No. Benefits Medical, dental, and vision coverage. Paid time off plan. Health savings account (HSA). 401(k) savings plan. Access to wages before payday with myFlexPay. Flexible spending accounts (FSAs). Short‑ and long‑term disability coverage. Work‑life resources. Paid parental leave. Healthy lifestyle programs. Equal Opportunity/Affirmative Action 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 Cardinal Health