Assistant - QA Document Control

At Elanco, the Assistant - QA Document Control plays a crucial role in supporting the site's overall document control system. This position is responsible for issuing manufacturing batch records and packaging procedures according to a predetermined schedule. The Assistant oversees controlled documents within the site document management system, maintains the document control filing system, and ensures compliance with site requirements for documentation, archival, and retention. Additionally, the role involves assisting during inspections to ensure that all documentation is in order and meets regulatory standards. The responsibilities of the Assistant include preparing, reviewing, and issuing batch records while ensuring compliance with Good Documentation Practices, regulations such as cGMP and 9 CFR, and company Standard Operating Procedures (SOPs). The Assistant manages document control systems, trains staff on good documentation practices, and maintains document traceability and retrieval. They are also responsible for implementing batch record holds based on deviation impact assessments, initiating deviations in quality systems for non-conformances, and ensuring timely Quality Assurance (QA) approvals. Maintaining the document control area in an inspection-ready state is a critical aspect of this role. In addition to these tasks, the Assistant actively participates in Corrective and Preventive Action (CAPA) teams, investigates deviations, and ensures the timely and accurate completion of CAPAs to address any non-conformances. The role requires strong teamwork and collaboration skills, as the Assistant will lead projects, contribute to idea generation, and drive process improvements. Participation in internal audits, preparation for regulatory agency audits, and customer inspections is also part of the job, including providing support during inspections and demonstrating job tasks as needed.