QA Document Coordinator (NCI) Job in Maryland (MD), Research and Development Career, Full Time Jobs in Leidos Biomedical Research, Inc.
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QA Document Coordinator (NCI) job in FREDERICK

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Leidos Biomedical Research, Inc. jobs
Maryland (MD), FREDERICK
Job Code:  659066
Employer:  Leidos Biomedical Research, Inc.
Category:  Research and Development
Job Type:  Full Time

Country:  United States
State:  Maryland (MD)



The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.


Reporting to the QA Document Control Supervisor, 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



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
- Microsoft Office (Work, Excel and Outlook)
- Internet Explorer
- Must be able to obtain and maintain a security clearance


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

Expected Competencies:

- Delivery of straightforward administrative and/or other basic business support or services
- Works within established procedures with a moderate degree of supervision
- Accountable for delivery of own work activities to agreed timescales and quality
- Impact will be limited, typically to the immediate team although wider impact likely in customer facing roles
- Has developed knowledge and skills through formal training or considerable work experience
- Applies knowledge of a body of standardized rules, procedures, operations, etc. within a specialized or technical field
- Problems are known, defined and readily apparent
- Selects best option from a set of defined procedures/solutions using common sense and experience of similar situations
- Non-routine issues typically escalated to more senior team member or supervisor
- Interacts with a range of individuals both within and outside immediate team to convey basic information

Leidos Overview:
Leidos is a global science and technology solutions leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit The company's diverse employees support vital missions for government and commercial customers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.

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