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Quality Assurance Specialist (Full Time/Temporary 3 Month Assignment)

HeiTech Services, Inc. Hyattsville ,MD
  • Expired: over a month ago. Applications are no longer accepted.
Job Description
Job Description

Job Title: Quality Assurance Specialist (Full Time/Temporary 3 Month Assignment) 

City: Hyattsville / State: Maryland                                                   


Position Summary

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.

 

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 desktops
    • 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 vocabulary specialist.

 

Work Conditions:

  • Work is primarily performed in an office environment.

 

Skills and Abilities Required

  • 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.
  • Possess or be able to obtain/maintain a Government Public Trust Security Clearance.
  • Attention to detail is MANDATORY
  • They shall possess excellent computer skills and experience with the querying and use of databases.

 

Minimum Education and Experience Required



  • High School Diploma Required/Bachelors Degree preferred, 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.


 

HeiTech Services, 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

 

Job 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.
  • Possess or be able to obtain/maintain a Government Public Trust Security Clearance.
  • Attention to detail is MANDATORY
  • They shall possess excellent computer skills and experience with the querying and use of databases.
Company Description
HeiTech Services, Inc. is a federal programs and technology solutions provider headquartered in Landover, Maryland. We specialize in delivering Business Processing and Information Technology Services. Incorporated in 1999, HeiTech Services has implemented effective management-oriented solutions specifically designed to reduce costs and streamline operations for our client base, which includes twelve federal government agencies.
Today, flexibility is a critical attribute for a successful services company. HeiTech Services focuses on the client’s mission and not the fine print! Our ability to creatively resolve unexpected budgetary or staffing issues drives our success. We view each client as a long-term partner and see new challenges as an opportunity to provide innovation and strengthen relationships.
HeiTech Services, Inc. is a privately-owned company employing hundreds employees in multiple locations on a nationwide basis. Through leveraging knowledge and best practices, acquired from all of our projects, HeiTech Services generates consistent value for our clients. We are committed to helping clients achieve their goals while being mindful of our core values of Honor, Excellence and Innovation.

HeiTech Services, Inc.

Why Work Here?

Awesome CEO, good work environment, and room for professional development

HeiTech Services, Inc. is a federal programs and technology solutions provider headquartered in Landover, Maryland. We specialize in delivering Business Processing and Information Technology Services. Incorporated in 1999, HeiTech Services has implemented effective management-oriented solutions specifically designed to reduce costs and streamline operations for our client base, which includes twelve federal government agencies. Today, flexibility is a critical attribute for a successful services company. HeiTech Services focuses on the client’s mission and not the fine print! Our ability to creatively resolve unexpected budgetary or staffing issues drives our success. We view each client as a long-term partner and see new challenges as an opportunity to provide innovation and strengthen relationships. HeiTech Services, Inc. is a privately-owned company employing hundreds employees in multiple locations on a nationwide basis. Through leveraging knowledge and best practices, acquired from all of our projects, HeiTech Services generates consistent value for our clients. We are committed to helping clients achieve their goals while being mindful of our core values of Honor, Excellence and Innovation.

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Hyattsville, MD
USA

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