The Quality Assurance Specialist is responsible, as a member of the Quality Assurance Unit (QAU), for implementing and maintaining the quality management system. The QA Specialist will assure that the quality assurance programs are maintained in accordance to pertinent regulatory requirements and internal SOPs in the performance of the duties of this position.Here's what you'll do: Maintain the Quality Management systemPerform document control activities.Provide quality support in writing, reviewing, revising, and maintaining standard operating procedures (SOPs), forms, presentations, and other business documents.Assure documents capture the current process, provide sufficient detail to perform the process, and comply with internal procedures for generating documents.Support the training program, such as creating training files and ensuring that they are updated and current as appropriate.Provide training sessions.Host meetings and/or scribe meeting minutes.Follow up on CAPA and Change Control systems, as appropriate.Perform internal audits to ensure compliance is maintained within the organization. May provide audit reports to the applicable audited function/area management. Cooperate in the preparation of study files prior to and during all client audits and regulatory inspections.Attend meetings and participate on multi-disciplinary teams, as required, to provide routine status updates related to their functional area and/or to provide quality guidance.Become a subject matter expert (SME) in a particular quality system (i.e. documentation, supplier quality, other) depending on experience, skill set, and business needs.Conduct QA reviews of study data generated when required.Generate QA statements for study reports when required
