The Quality Assurance Specialist will provide support and will assist the Quality Assurance Director in the oversight of quality systems. Will assist in Quality oversight and support the Analytics group and Operations group (Manufacturing, Stability, and Research & Development Groups) for the manufacture and testing of non-clinical and clinical products. The Quality Assurance Specialist will assist in Quality initiatives, maintaining/improving quality infrastructure, and participating where needed on various CMC and GMP/GLP-related project teams. The Quality Assurance Specialist will work with the QA Director to ensure compliance with the Quality Systems, supporting quality oversight at the project level and generation of metrics to drive continuous improvement while assuring the quality of materials manufactured and data generated.
Essential Duties:
Writes GxP documentation (i.e., SOPs, reports)Issues production batch records and associated packaging components per the Manufacturing schedulePerform room clearancesQuality monitoring of in-house manufacturing operations.Supports the disposition of raw materials, intermediates, and drug products and/or preventive actions for adequacy and logic of root cause analysis, and impact to both quality and regulatory commitmentsAssists the Quality Assurance Director in developing and utilizing tools to perform risk assessment, track and report quality metrics to management for Quality Management Review.Supports quality oversight of equipment, utility, and facility qualification activitiesAid in implementing process improvements concerning Quality Assurance, including managing OOS procedures and related reportingSupports external agency and internal audits as requiredSupports the Document Control System. Assist in the maintenance of the Document Control files (i.e., DCO Log); processes new/revised/retired documents in the current document management system. . Requirements: Working knowledge of cGMP principles concerning appropriate regulatory requirements (FDA, ICH guidelines)Ability and experience to identify technical manufacturing problems and suggest resolution of issuesAbility to independently analyze/resolve moderate to complex issuesDemonstrate initiative and accountability in a fast-paced environmentProficiency in application of QA principles, concepts, industry practices, and standardsProblem-solving skills, effective written and verbal communication skillsExcellent documentation skills and attention to detailHighly organized and able to manage multiple prioritiesAbility to work independently and with various workgroupsWorking knowledge of MS Office Suite (Word, PowerPoint, Excel)