GMP Documentation Specialist

Location
Frederick, MD, USA
Posted
Oct 29, 2018
Ref
req130
Hotbed
BioCapital
Required Education
Associate Degree
Position Type
Full time
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

GMP Documentation Specialist will:
  • 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 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 trouble-shooting of user requirements and appropriate workflows applicable to document system requirements
  • Maintains document security and Document Control 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
  • Possession of an Associate degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
  • In addition to the education requirement, a minimum of three (3) years of experience is required
  • Must be able to obtain and maintain a clearance

PREFERRED QUALIFICATIONS
  • Proficiency with Microsoft Office and the ability to maintain computer-based and hard-copy documentation filing systems
  • Proficiency in Adobe Acrobat Professional and electronic document management

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)”