Purpose An amazing opportunity has arisen for a Support Operations Quality Notifications and Investigations Specialist to provide operational support for manufacturing operations of our Late Stage and Launch Pipeline products at our clients new state of the art single use biotechnology facility. Responsibilities Author Quality Notifications: Take full ownership of drafting, reviewing, and finalizing Quality Notifications, ensuring clarity, accuracy, and compliance with regulatory requirements. Initiate and maintain quality related metrics related to Quality Notifications ensuring effective communication and follow up of the same. Quality Metrics: Ensure that Quality notifications (including CAPAs, Investigations and incidents) meet our metrics for raised on time and closed on time, while maintaining a high standard of technical writing and compliance. Incident Reporting: Solely manage the authoring of incident reports, documenting quality issues and ensuring timely submission for review and approval. Investigations Documentation: Lead the authoring of comprehensive investigation reports, detailing findings, root cause analyses, and corrective actions. Approval Process Management: Navigate the approval process for all authored documents, collaborating with cross-functional teams to ensure timely reviews and compliance with quality management systems. Quality Risk Assessments: Participate in Quality Risk Assessments as needed, providing insights and documentation to support the evaluation of quality risks. Continuous Improvement: Contribute to a culture of continuous improvement by identifying opportunities for enhancing documentation processes and quality practices. Compliance Adherence: Ensure all authored documents meet the necessary compliance standards and are aligned with the Manufacturing Division Quality Management Systems (QMS). Training and Support: Provide guidance to team members on best practices for documentation and compliance, fostering a culture of quality awareness Qualifications Bachelors degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.? 2 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components).? Position level will scale with experience level of candidate.? Strong technical writing capability and previous experience authoring reports and investigations in a GMP environment Competent in analysing complex situations and show practical problem-solving capabilities.? Ability to work independently and within a cross-functional team.? Experience in leading and facilitating Root Cause Analysis and Quality Risk Assessment sessions Experience supporting Regulatory Inspections and Site Internal Audits? Understanding of Upstream and Downstream Unit Operations for mAb manufacturing?