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. <?xml:namespace prefix = "o" ns = "urn:schemas-microsoft-com:office:office" />
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
Requirements:<?xml:namespace prefix = "o" ns = "urn:schemas-microsoft-com:office:office" />
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” amp; “batchelor+4 yrs = masters”).