Exception Management Specialist

Company: SOFIE
Location: Dallas
Posted on: May 28, 2023

Job Description:

Title - Exception Management SpecialistLocation - Home based (out of any SOFIE location) Department - Quality / ComplianceReports To - Quality Manager, Audits & InspectionsOverviewSOFIE is committed to all aspects of Quality and Compliance in the production of the Radiopharmaceutical products they manufacture. This role supports the Quality Manager, Audits & Inspections and provides Quality oversight to the SOFIE network. SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. Duties of the successful candidate will include, but are not limited to, writing, reviewing, and editing quality exception reports from all SOFIE facilities, performing root cause analysis and developing meaningful corrective actions to exception events, trending root causes for exception events network-wide, and escalating to management any adverse exception trends. This person will play an active and integral part of the Quality team supporting compliance and improvement at all SOFIE facilities. Essential Duties and Responsibilities Provide quality assurance support to the SOFIE Network. This includes writing, reviewing, and editing quality exception reports and assisting in the generation and review of change controls, corrective and preventive actions, procedures, protocols, and other documents applicable to SOFIE and partner products. Be a quality liaison, develop solid relationships, and establish open communication with SOFIE network sites, specifically Quality Assurance Specialists and Regional Quality Assurance Managers. Learn and have knowledge of SOFIE processes, products, and systems.Provide Quality support to maintain, and continually improve the Quality Management System (QMS). Author, review, edit, and approve site-level and corporate exception reports including Out of Specification (OOS), Deviation, No or Atypical Yield (NAY), Complaints, and Environmental Monitoring events.Provide feedback and assistance to site personnel on exception reports.Assist sites in completion of exception reports.Review site-level and corporate exceptions trends. Perform root cause analysis and develop meaningful Corrective and Preventive (CAPA) actions to address exception events.Trend site-level and corporate exception events.Review exception event trends to initiate corrective and preventive actions and/or for continuous process improvement.Identify non-compliance problems and propose solutions as appropriate. Effectively interact with other functional personnel at the site and corporate level and resolve quality related issues. Initiate CAPA action plans and Change Controls to prevent cGMP non-compliance and product quality problems proactively. Ensure continuous and sustained improvements. Continuously seek to improve exception report writing and handling.Be a Subject Matter Expert resource for the entire network for the key area: Technical Report Writing. Perform other tasks as required by the Quality Manager, Audits & Inspections.Domestic travel up to 20%. Qualifications Bachelor of Science Degree (B.Sc.) in an appropriate scientific subject, e.g., Chemistry, Microbiology, Quality and Regulatory Affairs, Regulatory Science, etc. preferred but will entertain applicants with relevant education and work experience. 2+ years of work experience in Quality Assurance in a cGMP pharmaceutical and/or biological manufacturing regulated environment preferred. Experience writing technical reports required.Familiarity with radiopharmaceutical manufacturing processes and related QC release testing preferred. Working knowledge of CGMP regulations and guidelines, risk management standards, quality attributes, and Quality Assurance best practices in the pharmaceutical industry required. Experience working with customers and partners preferred. Excellent analytical, prioritization, multi-tasking, communication, and the ability to work independently with limited supervision required. Ability to effectively communicate (written and verbal) with site personnel, corporate QA, customers, and regulatory agencies required. Ability to prepare and present written and verbal reports to upper management required. Ability to project manage and have excellent organization and prioritization skills. PDN-98ded4b6-bb1d-4ce8-b01f-f45a715f592c

Keywords: SOFIE, Dallas , Exception Management Specialist, Executive , Dallas, Texas