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Job Field: Government Jobs
Location: SALT LAKE CITY, UT
Job Type: Full Time

JOB SUMMARY:

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JOB SUMMARY: Perform QAAD software and system configuration, technical requirements gathering, integration with third party systems, and any required validation services for the QAAD and MasterControl suite product lines. Responsible for ownership of customer project tasks and issues that are addressed to him/her and applying company resources and methodologies to provide timely services delivery and solve issues. JOB DUTIES: ? Develop user documentation such as training manuals and functionality-based test scripts. ? Provide client training on use of QAAD and MasterControl software. ? Provide customers with consultation services for development of validation documents. ? Provide advice on the use of QAAD and mapping quality assurance processes to QAAD functionality. ? Provide user support, either at user site or via telephone, email, fax, or WebEx. ? Become in-house expert on the use of current and new releases of QAAD. ? Provide feedback to ensure the online help and training documentation provides optimal benefit to all clients. ? Provide input into software design requirements where appropriate. ? Facilitate user group meetings and Web Training Meetings ? Prepare draft Proposal and Statement of Work (SOW) documents detailing training and implementation project work with existing clients as required. ? As necessary, work with Technical Support and Engineering staff to resolve customer issues. ? Communicate findings from fieldwork to project management and product management as applicable. ? Create and maintain strong working relationships with customers. ? Provide validation service tasks as required, including but not limited to: o Validation documentation creation o TOQ and risk assessment delivery o OQ script execution o PQ script creation o PQ script execution o Validation report documentation preparation REQUIREMENTS: ? Bachelors degree in Physical or Life Sciences, or Quality ? At least 5 years experience in a Quality role in a life sciences industry ? ASQ, MQRA or equivalent quality certification ? Mastery of QAAD software program (at least 12 months experience with QAAD system administration) ? Ability to validate client data and write scripts ? Expertise in good laboratory practices, good clinical practices and good manufacturing processes (GLP, GMP and GCP compliance) in US and European regulatory environment ? Experience in project management ? Must be willing to travel. Interstate domestic travel to client sites required about 60% of work time.

KEY REQUIREMENTS:

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Bachelors