Quality Assurance Specialist

FEFA LLC has an immediate need for a full-time, Quality Assurance Specialist (QAS) for one of our Federal Government contracts in Silver Spring, MD.  The position is 100% on site at White Oak.

Position Summary:

• Analyze incoming documents and reports for completeness and compliance with the customer's guidelines and take appropriate steps to capture the pertinent information into databases and IT systems.
• Perform accurate and timely data entry using multiple screens in customer's system and classify/index/assign the records appropriately.
• Maintain paper and electronic records in accordance with customer's established guidelines.
• Perform document entry services, data analysis, tracking services, and stakeholder/user support
• Handle phone calls and emails from internal and external stakeholders and the public
• Perform data quality assurance (QA) and quality control (QC) with critical attention to detail
• Collect statistics and assist in providing input for periodic reports.
• Eliminate outdated, unnecessary, or duplicate materials, properly destroying them as requested
• Assist in audits and verification of work in process
• Pick up, process, and distribute large volumes of inter-office and incoming mail

Requirements

Education, Related Experience and Qualifications

• HS Diploma.

• Minimum of 3 years of increasingly responsible experience in records and document management
• Proficient in reading, analyzing, classifying, and interpreting complex narrative of regulatory submissions
• Experience in document processing and related quality control activities
• Experience in document tracking, records inventory, and scanning
• Must be able to implement SOPs and train staff in their use
• Excellent verbal and written communication
• Excellent demonstrated customer service skills
• Must be proficient in using computers, demonstrated use of Microsoft Office

• Must type a minimum of 60 wpm
•  Proficiency with Excel spreadsheet creation
• Must be US Citizen - Possess or be able to obtain/maintain a Government Public Trust Security Clearance

• Background in quality control processes, document tracking, inventory management, and Must have experience in quality control, overseeing document tracking databases, inventorying records, and scanning is highly desirable
• Must be highly self-motivated, organized, skilled at time management, and extremely detailed oriented with strong ability to perform quality checks on the work being performed
• Must complete assignments adhering to all FDA/Federal rules, regulations, policies, guidance documents, and procedures
• Work Hours:  Normal business hours; Monday – Friday, 8:00 – 4:30 pm

Benefits

FEFA LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.