QA Technical Writer
The Civil Health Operation is currently looking for a QA Technical Writer position to support a large healthcare contract in Atlanta. This position is contingent upon contract award.
The QA Technical Writer is responsible for working with subject matter experts to write and edit technical documentation while ensuring compliance with applicable regulatory requirements. The QA Technical Writer creates, manages and oversees the generation of technical documents in support of Operations, Quality Assurance, Quality Control, and data entry activities. The QA Technical Writer works on assignments that are complex in nature where analysis of processes and data requires an in-depth evaluation of various factors.
Main Job Tasks and Responsibilities
· Review regulatory documents for clarity and consistency
· Develop, define terminology used in scientific and regulatory documents to ensure easily understood by all audiences.
· Develop and maintain training curriculum and training records - include interviewing Subject Matter Experts to collect training requirements and technical content
· Develop, maintain, revise, and test division Standard Operating Procedures – include interviewing Subject Matter Experts and SOP user community and analyzing optimum work process
· Produce documents and manage files within a controlled systems environment (workflow, permissions, versions, etc.).
· Review, suggest, revise, consult and rewrite existing Select Agents and Import Permit guidance documents.
· Contribute to the development of informational or technical documentation including Select Agent and Import Permit documentation, regulatory documents, communication materials, website materials in electronic, hardcopy, and/or video format.
· Perform other QA related duties as assigned, including developing specific QA techniques and process, verifying data entry accuracy, auditing record management files, and troubleshooting operational issues.
Knowledge Skills and Abilities:
· Ability to read and interpret regulations, guidance documents, technical manuals, handbooks, forms and related instruction guides.
· Excellent analysis, communication, organization, planning, problem-solving and follow-up skills.
· Ability to work effectively as a team player in a diverse work group.
· Demonstrated ability to research, organize, and develop writing projects for technical and regulatory content/literature for both technical/scientific and general public audiences
· Ability to accurately convey information in both spoken and written form.
· Strong command of the English language is essential.
o Experience in creating multi-media training materials and/or maintaining web content are preferred
At least 3 years of experience
Ability to obtain a Public Trust 5 and/or Secret clearance
Previous CDC and/or CDC Division of Select Agents and Toxins experience a plus.
Note: specialized experience can be substituted for formal education (“4 yrs = bachelor’s” & “batchelor+4 yrs = masters”).
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 www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.