Quality Assurance Specialist

Security Clearance Must possess or be able to obtain a Public Trust Clearance. Location This position requires onsite attendance in the office (Landover, MD) during the training period. After successful completion of training, the role may be eligible for remote or hybrid work arrangements. Essential Duties And Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Perform quality control and control of the data entry and correctness, document control & processing, and the overall quality of the performance of the scope of work. Perform investigations for the resolution of problem reports using various desktop applications. Create and update excel spreadsheets to record the resolved problem reports. Process paper and electronic documents in accordance with current SOPs as FDA moves away from a total paper environment to an electronic paperless environment. Redact patient and/or manufacturer data. Daily use of office automation tools such as Microsoft Office and other common desktop applications. Make necessary changes to the work process, when requested. Provide quality control by reviewing completed work projects to ensure data accuracy, completeness and timeliness. Function as the vocabulary specialist. Requirements Technical background with knowledge of folder structure systems for electronic documents. Proficient with office automation tools such as Microsoft Office and other common desktop applications. Must have a combination of excellent analytical skills and attention to detail. Possess excellent verbal and written communication skills. Must be able to work in a fast‑paced paper and electronic production environment. Must have experience with reading and classifying scientific regulatory documents. Must have experience and working knowledge of the FOIA and redaction process. Must possess excellent customer service skills. Attention to detail is mandatory. Shall possess excellent computer skills and experience with the querying and use of databases. Minimum Education And Experience Required Bachelor’s Degree, preferably in health or science related field AND/OR experience demonstrating an ability to use medical device terminology, understanding of policy issues, and experience in performing editing of documents. Three (3) years related experience with two (2) years direct experience processing documents and at least one (1) year of office, records, or computer experience. Must have knowledge and experience with medical devices and medical device terminology. Ability to type 40 words per minute with no more than two errors. Equal Opportunity Employer HeiTech Services is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, veteran status, or any other protected status under applicable law. If you require a reasonable accommodation during the application process, please contact us at View email address on click.appcast.io. #J-18808-Ljbffr