Technical Writer needs 1 year experience

Lab Technician II requires:

• 21cfr and cGMP knowledge


• 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.

Lab Technician II duties:

• Technical Writer III - Reports to Engineering Lead.


• 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