OnX Enterprise Solutions Silver Spring, MD, USA
Sep 05, 2019
We are looking for a Quality Assurance Generalist to work on a full-time basis in our Germantown, MD facility. This position is responsible for ensuring that the Company meets its business objectives through the effective implementation, management and auditing of the Company s quality systems. Essential Functions To comply with the Company s Health and Safety, and Radiation Safety Program. To act as the Company s Archivist to comply with current GLP and GCP regulatory practices. Maintain the physical secured archive area and archived records and maintain the archive server. Coordinate with operations to ensure all completed records are archived. Communicate with the study Sponsor regarding disposition of paper and electronic records. Maintain the archive spreadsheet and all necessary paperwork. Coordinate with subcontractors for the long-term archiving of records and samples, if necessary. Ensure that all study records are scanned and electronically archived, when necessary. Coordinate with Quality Assurance to facilitate audit of archiving activities. To maintain and report on the archive status of all completed records To manage the Document Control Program. To maintain the Master Document List, process documents for use by the Company, and retire obsolete documents. Quality Assurance Unit to adhere to the operations of the QAU and to make recommendations for further implementation or improvement of any of its systems. To prepare standard operating procedures for use by the Company as required. To assist the Company meet its business objectives by demonstrating to Sponsors the quality processes and continuous improvement activities within the Company. Required Education, Knowledge and Experience High School diploma or equivalent; At least 1 year of archiving or records management, and clerical experience.