Hiring: Senior Specialist, Quality Assurance Company: Cardinal Health Location: Fort Lauderdale, FL Job Posted Time: 2026-09-10 11:24:31 Employment Type: On-site Target Skills & Keywords : Microsoft Excel, Quality Assurance, SAP About the job Experience: •1-2 years of experience in Quality Assurance and/or regulated environment preferred; cGMP, highly preferred. •2+ years of experience in related science field preferred •2 years of experience in Quality Assurance and/or regulated environment preferred; cGMP, highly preferred. Required Skills: •Primary focus in the role is to deliver QA support for the review and approval on all operational documentation as it relates to the technical transfer project such as protocols, validation documents, etc. This role will be accountable to the technical transfer leadership team while executing tech transfer projects. •Travel to other PET manufacturing sites network-wide to provide quality review of technical transfer projects when required. •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. Qualifications: •Bachelor's degree in related field, or equivalent work experience, preferred •Pharmaceutical or medical device experience a plus •Effective written and verbal English communication skills •Demonstrated capacity to manage several tasks at the same time; Ability to focus on tasks; Ability to evaluate operating conditions. •Demonstrated capacity to exercise sound judgment Personal Protective Equipment. •Knowledge of quality systems and approaches •Proficiency with SAP, Microsoft Excel, Microsoft Word, Microsoft Outlook, and Microsoft Power Point. •Understanding of the requirements and can perform gap assessments to those requirements, a plus •Demonstrated capacity to analyze and interpret results from chromatograms by HPLC, Gas Chromatography, and E-Z Scan radiometric TLC scanner, a plus •Understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving, a plus Compensation: •$68,500 - $88,020 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!