QA Batch Release Supervisor - IDAP

Job Description

Working closely with the QA Manager, the QA Batch Supervisor will be instrumental in supporting major QA programs. They will also be key in championing and developing the organization’s Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. The QA Batch Release Supervisor will at all times provide support with identifying and closing Operational and Quality gaps. The Quality Assurance Batch Supervisor will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and external partners and clients. The QA Batch Supervisor will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Batch Supervisor will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Batch Supervisor will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions: · Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product. · Manage and oversee the Batch Record “real time” floor review process. · Provide Client access and support in the review and approval of Batch Records · Design and own an ongoing QA Surveillance program for the assurance of compliance standards in operations areas. · Provide training to all QA Associates and Specialists on surveillance oversight and on-the-floor Batch Record review requirements. · Participate in operations investigations for determining root cause and assessing mitigation for Major and Critical deviating events. · Responsible for updating SOP’s & Work Instructions. · Support Plant Autom