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QA Document Control Associate

QA Document Control Associate

ID 
2017-1097
Category 
Quality Assurance
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

This position is responsible for scanning and performing quality checks of GMP documents. The individual will also provide coverage in the document archive room and assist with organizing, retrieving and filing GxP documents. The individual will interface with various departments requesting and reviewing documents daily.

 

Responsibilities and Job Duties:

  • Scans batch records, test data, protocols, reports and places into their respective electronic folders daily. 
  • Conducts quality control reviews of scanned documents for accuracy and completeness daily. 
  • Serves as document room attendant and archivist to ensure that access is granted when needed to authorized individuals, and that documents are properly distributed and stored. 
  • Ensures that documents are signed out for review and signed back in after return and that appropriate logs are maintained. 
  • Catalogs and boxes scanned GxP documents in accordance with internal policies to send to off-site storage.
  • Communicates any issues or concerns to supervisor.
  • Other duties as assigned. 

Qualifications

Education 

 

A high school diploma is required.

 

Experience

  • A minimum of 2 years of experience working in a records management environment is required. 
  • Experience using MicroSoft word is required. 
  • Experience using copiers and/or high-speed scanners.

Knowledge, Skills and Abilities

  • This position requires a keen aptitude for details and accuracy.
  • Must have excellent interpersonal skills.
  • Must be very detail oriented.
  • Must be able to manage and prioritize multiple projects at once. 
  • Proficient using MicroSoft Office software.
  • Ability to work diligently with minimal supervision.
  • Ability to meet tight timelines.
  • Ability to stand for long periods of time.

Supervisory Responsibilities

None

 

Preferred Qualifications

  • Prior experience working in document control or in a records management role preferred.

 

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.