Research Triangle Park, NC3 days ago
Escalate unresolved issues or concerns to Quality Management and affected area management + Participate in client meetings and projects as it relates to manufacturing, product scheduling, batch records, supply chain, etc. to support product pipelines + Support regulatory authority (FDA, MHRA, EMA, QP, etc.) inspections and internal audits, including documentation audit team, pre-audit facility inspections, etc Minimum Requirements + Bachelor’s Degree in a scientific or related technical discipline + 5+ years of relevant pharmaceutical industry experience in a cGMP regulated environment + Ability to work independently and part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines and work extended hours to support business needs + Able to work extended hours to support business needs, as applicable + Experience in review of batch records, production records, process control records + Ability to interpret data in relation to a vast number of company procedures as well as current GMP requirements + Ability to effectively communicate (written and oral) with internal and external customers at various levels in the organization + Ability to handle confidential company data, projects, information, etc. + Review GMP documentation, including logbooks, pest control, waterlogs, calibration and maintenance reports, temperature monitoring, batch records, protocols, etc., as it relates to Combination products for accuracy, completeness, and compliance with UT policies and procedures + Perform quality assurance functions, including inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections and floor audits, in support of manufacturing and packaging operations + Review and disposition manufacturing, packaging and Combination Products batch records and raw materials and components for clinical and commercial processes + Review of quality control final product and stability data + Process rejected lots of raw materials, components and Combination products identified for destruction.