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Date Added: Tue 15/06/2021

Technical Information Specialist (FDA)

Hyattsville, MD, US
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Company: AMTIS INC

Job Type: Permanent, FullTime

Job Description

Position Description:

The person in this position is responsible for conducting quality control on submissions received for our customer, the Food and Drug Administration (FDA). The primary functions include but are not limited to: performing all quality controls on documents processed and interfacing with our clients to answer questions on how the work is being processed. The Technical Information Specialist may also be permitted to make changes to the work process. Although Technical Information Specialists will be assigned to perform these primary functions shown above, they may also be cross-trained to perform secondary duties according to business needs.

Required Qualifications:

  • High School Diploma
  • Two (2) years direct experience processing documents and at least one (1) year of office, records, or computer experience
  • Ability to type 40 words per minute with no more than two (2) 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
  • Must be able to lift and move standard boxes (up to 50 lbs)
  • 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 possess excellent customer service skills
  • Have experience in working areas such as document tracking databases, scanning and micrographics
  • Requires ability to bend and stretch to reach files, and push a fully loaded mail cart
  • Possess or be able to obtain/maintain a Government Public Trust Security Clearance
  • Excellent data entry skills and attention to detail is MANDATORY

Preferred Qualifications:

  • Bachelor's degree in Science or Information Management
  • At least three (3) years experience in an office environment with a records management background

Essential Functions:

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
  • Perform quality control checks on processed documents according to project requirements with 99% accuracy
  • Use office automation tools daily such as Microsoft Office and other common desktop applications
  • Use client specific databases with great proficiency
  • Make necessary changes to the work process, when requested
  • Able to become a resident subject matter expert
  • Provides quality control by reviewing completed work projects to ensure data accuracy, completeness and timeliness
  • Provide assistance to FDA Division personnel

Work Conditions:

  • 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.



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