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Documentation Specialist II

Job ID: req1901
Employee Type: exempt full-time
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 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 Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the National Cancer Institute (NCI) and other government agencies through the development of novel agents for first-in-man clinical studies.

 KEY ROLES/RESPONSIBILITIES

  • Responsible for formatting, word processing, storing, and controlling the distribution of documents (hard copy and electronic) pertaining to the operation of the BDP, as defined by relevant document control Standard Operating Procedures (SOPs) and in accordance with CGMP regulatory agency requirements. Issues, distributes, maintains, and controls CGMP documents. Reviews documents for grammatical and format accuracy
  • Supports the supervisor/manager in the establishment and troubleshooting of user requirements and appropriate workflows applicable to document system requirements
  • Maintains document security and Document Control systems/databases as appropriate
  • Maintains SOP Manuals for compliance and works with supervisor on recommendations for updates/revisions
  • Monitors and tracks the review, approval, and distribution of documents to ensure timely completion to meet established timelines. Manages follow-up progress with various departments to ensure completion of documents
  • Assists with QC accessioning administrative functions (QC report scanning and archival)
  • Interacts with internal staff and customers to obtain and provide documentation to meet customer and FDA requirements
  • Performs other duties as assigned

BASIC QUALIFICATIONS

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

  • Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency  
  • In addition to the education requirement, a minimum of two (2) years of progressively responsible experience
  • Ability to obtain and maintain a clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Three (3) years of job related experience
  • Proficiency with Microsoft Office 365/2016 and the ability to maintain computer-based and hard-copy documentation filing systems
  • Proficiency in Adobe Acrobat Professional and electronic document management
  • Proficiency with Master Control eDMS
  • Familiarity with GMP terminology and/or documentation

EXPECTED COMPETENCIES

  • Ability to communicate effectively orally and in writing
  • Excellent attention to detail and the ability to multi-task
  • Excellent organizational and interpersonal skills
  • Excellent written and oral communication skills with the ability to prepare reports, arrange meetings, and schedule and coordinate work

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

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