contract position-8 months
Send resumes to: bciociola@covexllc.com

Job Description:
Technical writer will be responsible for the following:
Composing Product Quality Complaint handling documentation including but not limited to SOPs, Work Instructions, and training materials. Reading existing documentation (and other material) to become familiar with current and desired future state processes. Adhering to Good documentation practices. Authoring documentation using future state process maps and other items already created by the Quality Team . Some independent work will be necessary to gather information via interviewing/interacting with personnel to author documents. Proofing created documents for formatting against a standard. Soliciting and incorporating feedback from personnel into authored documents. Assuring authored documents are in compliance with Documentation Control and Training requirements. Obtaining the required training to be able to use all tools and aspects of the Enterprise Data Management (EDM) system.

Educaiton:
Bachelor's Degree - preferrably in a scientific or technical field. Fluent in English

Experience/Technical Competencies:
Technical writing experience in an FDA regulated industry environment required - preferrably Product Quality Complaints. Must have prior experience authoring GMP documents such as Standard Operating Procedures, Validation Documents, etc. Knowledge of GDP also required. Prior experience with an electronic document management system is desired.

Job Knowledge/Skillsets:
Great attention to detail and the ability to communicate well with others is required. The successful candidate must have strong interpersonal skills and the ability to work well with others. The ability to work under strict time constraints and meet deadlines in a timely manner is required. The selected candidate must be comfortable working with computers and fluent in various Microsoft Office Applications (e.g. Excel, PowerPoint, Word, Visio).

Travel:
<10%