This position is responsible for ensuring the document quality controls are enforced in support of our customer, the Food and Drug Administration (FDA). There are two primary functions to which the Quality Assurance Specialists are assigned: Performing all quality control checks for data entry teams and serve as a medical device vocabulary specialist. While Quality Assurance Specialists may be assigned to perform these primary functions shown above, they will also be cross-trained to perform secondary duties according to business need.
- Please note: This is a temporary, full-time position with benefits. It is estimated that the work for this position will last for a minimum of two months with the possibility of an extension.
- 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 data entry.
- 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 attention to detail.
- Possess excellent verbal and written communication skills.
- Ability to work in a fast-paced paper and electronic production environment.
- Experience with reading and classifying scientific regulatory documents.
- Excellent customer service skills.
- Experience in working areas such as document tracking databases, scanning and micrographics.
- Possess or be able to obtain/maintain a Government Public Trust Security Clearance.
- Excellent data entry skills are MANDATORY.
- Excellent computer skills and experience with the querying and use of databases.
- Lifting and moving standard boxes (35 lbs).
- Requires ability to bend and stretch to reach files, and push a fully loaded mail cart.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Process paper and electronic documents in accordance with current SOPs, as FDA moves away from a total paper environment to an electronic paperless environment.
- Perform data entry functions, as needed.
- Redact patient and/or manufacturer data.
- 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.
- Respond to Export Certificated inquiries received from Stakeholders.
- Read and respond to email messages concerning the processing and certification of certificates.
- 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 the vocabulary specialist.
- Work is primarily performed in an office environment.
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.
AMTIS Inc. is an equal opportunity employer providing equal employment opportunities (EEO) to all applicants without regard to race, 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.