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Quality Auditor

Company: Software Guidance & Assistance
Location: Austin
Posted on: August 1, 2020

Job Description:

Location Austin, TX Essential Job Functions Provides operational support the Clinical North America QA Department. Ensure policies and procedures are monitored and updated to include regulatory changes. Assist with development, implementation, and maintenance of Standard Operating Procedures (SOP) and Work Instructions (WI) for the Austin facility. Help implement and evaluate QA standards that comply with GCP, ICH and industry regulations. Aid in the development of quality procedures for documenting audits and other quality assurance activities Assist with investigations of non-conformance issues, identify areas for improvement in the quality system, and assist with compliance outcomes with corrective and preventive actions. Supports the preparation of reports to communicate outcomes of quality activities. Identify training needs and organize training interventions to meet quality standards. Performs internal process and training record audits as scheduled. Supports the coordination of on-site audits conducted by external providers. Must be able to work with minimal supervision. Perform other work-related duties as assigned and required. Experience Education Bachelor's degree required, preferably in a life sciences discipline, nursing or related field. A minimum of 3 years of experience in clinical research, pharmaceutical or CRO industry required A minimum of 2 years of quality assurance GCP auditing experience in the pharmaceutical or CRO industry required Advanced knowledge of FDA guidelines, Good Clinical Practices (GCP), ICH, and other applicable regulations is required. Experience with performing vendor and system audits preferred Knowledge Skills Abilities Must show ability to present solutions to issues using good judgment must show ability to apply previous lessons to future project work Must make effective decisions on managing tasks within time constraints so that deadlines are not missed Is expected to seek direction for regulatory issues or issues that require significant changes to standards Is able to foster teamwork inside and outside the department Requires excellent oral and written communication skills to interact with other team members, partners, and sponsors Must be able to build rapport and effectively communicate issues and potential resolutions to team and supervisor Must show excellent interpersonal communication skills with a focus on customer service Must exhibit positive, professional demeanor in all communications with other employees, management, sponsors and other outside personnel Must exhibit concise technical writing skills in English with minimal grammatical or logical errors Must have high level of attention to detail and ability to plan and organize Must be knowledgeable in data collection, management, and analysis and in related problem solving Solid knowledge of computers, Microsoft Office products, and databases

Keywords: Software Guidance & Assistance, Austin , Quality Auditor, Other , Austin, Texas

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