Quality Assurance Coordinator - Pharmaceutical

Description:This position will be responsible for workflow management and review of change control documentation and documents in Document management system, issuance of production work/support orders, tracking pending tasks in electronic quality management system and coordinate/follow up for completion.Essential Job Duties:Responsible for review and workflow management of change control records in electronic Quality Management System (Veeva)Responsible for review of change control and associated requirements documentation for accuracy, completeness, compliance with cGMPs and applicable standardsWill generate reports on a scheduled basis for the status and tracking of open change control recordsResponsible for follow-up on status/open items related to change controlResponsible for issuance of tag-outs for equipment/facilities as required by change controlGenerate reports and data for Key Performance Indicator reportingCoordinate and follow up to ensure timely completion of change control requirements for shutdown projects including authorization of area back to production and product releaseResponsible for processing and maintenance of documents in Document Management System managing workflows of review, approval, issuance, and effective.Assist as needed for projects related to document management systems and change controlFamiliar with Microsoft Excel, eQMS, Access to utilize for tracking, trending, and data entry.Communicate effectively with multiple departments in order to provide customer service.Job Requirements:Bachelor's degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience. Related cGMP industry experience is desirableExperience working with eQMS highly desirableAbility to keep neat, accurate and complete records and logs.