Please note that this is a 4 months contract position.
Bachelor's Degree with emphasis on Technical Writing / Engineering Minimum of 1 year of technical writing experience in business and engineering setting • Knowledge of 21CFR Part 820, cGMPs, and ISO 13485:2003 standards. • Proficient in computer skills and MS Office package, especially MS Word. • Good oral and written communication. Must be able to develop and present data in different formats. • Must possess knowledge of Good Manufacturing Practices and should be able to work independently. • Must have attention to detail, accurate documentation with proven organizational skills. • Must possess interpersonal skills to effectively work in teams.
Reports to Engineering Lead. Responsibilities: Initiates, writes and revises procedures through Change Control. May coach others associated in these duties. • Initiates, writes, and revises technical documents including, but not limited to, engineering protocols, summary reports, standard operating procedures and specifications under the direction of engineering. • Uses Company's Change Control procedures from initiation of documents through approvals in validated Document Control system. • Reviews documentation for completeness and content, promoting cGMPs and proper safety and environmental practices. • Performs periodic assessments of document content to ensure accuracy and completeness. Determines if improvements can be made to streamline the process, and implements changes, as needed. • Will participate as a team member on project team to implement a new high speed automated production line. • Complies with mandatory Company annual training requirements. • Uses appropriate business systems within company and department requirements and maintains passwords accordingly. • Maintains acceptable quality records for documentation practices. • Basic understanding or awareness for validation/experiment/non-production events. Must be able to coach others and be able to work in teams
Applicants must provide their phone number. Reference job number A370.