Easter Seals Jobs

Quality Assurance Specialist (FIRF - TO 2)

Location:Landover, MD

Status:Full-time

Position Description:

This position is responsible for ensuring the document quality controls are enforced in support of the Food and Drug Administration (FDA). The primary functions of the Quality Assurance Specialists (QAS) are to perform 100% quality control checks for data entry and/or editor teams and ensure correctness, document control/processing, and the overall quality of deliverables within the scope of the work requirements. In addition, the QAS will function as a vocabulary specialist, having knowledge of and experience with medical devices and device terminology in a commercial environment or in a health information processing environment. While the QAS may be assigned to perform the functions above, they will also be cross trained to perform secondary duties according to project business needs.

Required Qualifications:

• 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.
• 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 a high attention to detail.
• Possess excellent verbal and written communication skills.
• Must be able to work in a fast-paced 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.
• Possess or be able to obtain/maintain a Government Public Trust Security Clearance.
• Must possess excellent computer skills and experience with the querying and use of databases.

Essential Functions:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Perform quality control of the data entry and editors to ensure correctness, document control and processing, and the overall quality of deliverables within the scope of the work requirements.
• 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 into an electronic paperless environment.
• Redact patient and/or manufacturer confidential 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.
• Provides quality control by reviewing completed work projects to ensure data accuracy, completeness, and timeliness.
• Function as a medical vocabulary specialist.

Work Conditions:

• Work is primarily performed within a hybrid work environment with some work performed onsite and some telework.

This document is not intended to cover or contain a comprehensive listing of all job-related activities, duties or responsibilities that are required of the employee.Due to the nature of the industry, job tasks may be changed as necessary to meet the needs of the customer.

BlackFish Federal is an equal opportunity employer providing equal employment opportunities (EEO) to all applicants without regard to ace, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://blackfishfederal.applicantpro.com/jobs/3495464-627036.html