QA Batch Specialist

INCOG are looking for a Quality Assurance Specialist – Batch Review who will oversee review processes for Manufacturing Batch Record lifecycle activities, including Formulation, Filling, Inspection, Labeling and Packaging, and final-stage review and disposition at a new state-of-art contract development and manufacturing organization. What Working closely with the QA Supervisor, the QA Specialist – Batch Review 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 Specialist – Batch Review will at all times provide support with identifying and closing Operational and Quality gaps. Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product. Provide Client access and support in the review and approval of Batch Records. Provide training to all QA Associates and Specialists on surveillance oversight and on-the-floor Batch Record review requirements. Support Quality Systems with driving timely completion of batch impacting deviations to support on time batch release activities. Create and report batch release metrics to site leadership. Participate in operations investigations for determining root cause and assessing mitigation for Major and Critical deviating events. Support authoring, reviewing and approving of various SOPs & Work Instructions. Advise and approve the builds of Batch Record BOMs and ECOs. Prioritize and coordinate their time in balancing production timelines with product quality assurances. Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escape the issue to Manager for resolution. Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. Utilize various paper and automated systems (eDMS, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. Ability to manage multiple projects in a fast-paced environment. Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. You! Ideally, candidates will have a Bachelor’s degree in a scientific discipline, along with 4 years of GMP experience. Of that experience, a minimum of 2 years should come from aseptic processing within cleanroom and/or isolator environments. Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships. #J-18808-Ljbffr Lead Candidate