Job Details - QA Document Coordinator - 40140548 | Frederick National Laboratory Talent Network
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QA Document Coordinator in Frederick, MD

Location: Frederick, MD
Career Level: Entry Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

QA Document Coordinator

Job ID: req1998
Employee Type: nonexempt full-time
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

 Position Overview:

PROGRAM DESCRIPTION

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g. HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

KEY ROLES/RESPONSIBILITIES

The QA Document Coordinator will:

  • Receive, scan, sort, and file documentation according to the organizational filing system (electronic and paper-based)
  • Develop and maintain electronic and paper file structures
  • Use and understand the electronic document management system (eDMS) to file/retrieve electronic documentation
  • Format and route documentation for review and/or approval via the electronic workflow process or paper-based system
  • Provide access to documentation for employees
  • Prepare documentation to be shipped to the off-site storage vendor
  • Support the day-to-day activities of the document control group, such as copying, printing, and setting up folders for filing documentation in the record centers
  • Create logbooks
  • Assist in the writing of standard operating procedures (SOPs)
  • Issue and reconcile GMP controlled documents (e.g., production batch records, validation protocols, etc.)
  • Track and reconcile documentation via logbooks and Excel spreadsheets

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of a high school diploma or equivalent
  • Two (2) years related experience including one (1) year at the level of Document Coordinator/Processor I
  • Ability to understand and navigate complex file structures and set up and maintain filing systems
  • Ability to operate a variety of office equipment (e.g. computer, fax, scanner, copier, printer)
  • Knowledge of common office practices and procedures: typing, filing, scanning, English grammar, punctuation, spelling, and abbreviations
  • Experience with Microsoft Office (Work, Excel, and Outlook)
  • Experience using Internet Explorer
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Previous experience as a document coordinator, secretary, or administrative assistant
  • An understanding of controlled documentation
  • Previous experience in GCP, GLP, or GMP regulated environment

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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