Technical Writer - II

Hello this is Komal from Intellectt we have an opening for a Technical Writer - II in Des Plaines, Illinois. Please find the job details and description below and if interested You can reach me at komal@intellectt.com or call me at 1(732)-813-9025.

Role: Technical Writer - II

Location:Des Plaines, Illinois - 60018-3315

Duration: 12 Months on W2

Shift Timings: 8 AM to 5 PM

Job Description

• Writes a variety of technical articles, reports, brochures, and/or manuals for documentation for a wide range of uses.
• May be responsible for coordinating the display of graphics and the production of the document.
• Familiar with standard concepts, practices, and procedures.
• Relies on limited experience and judgment to plan and accomplish goals. A certain degree of creativity and latitude is required.
  
  

Additional Notes:

• Bachelor's Degree in general biology with a focus in a specific discipline (i.e. cell biology, microbiology, molecular biology).
• Some experience in that discipline 2-4 years preferred.
• Familiarity with GMP and GLP and good documentation skills.
  
  

Core Job Responsibilities:-

• Conducts statistical analyses of assays, learns basic understanding of the principles of assay and instrument (hands-on knowledge and skills) and performs molecular diagnostic assays.
• This position is responsible for initiating and managing the change control packages primarily for device master records and gathering specific medical device attributes to support new European Union regulations.
• Medical device attributes: As the new European Union regulations become effective, gather attributes associated with each medical device (100 ) by evaluating product labeling, designed records and device master records per established timelines.
• Change control: Document types may include Manufacturing Procedures, Quality Control Procedures, Certificates of Analysis, and Material Specifications (and in some instances Labels/Package Inserts).
• Ensure thorough well drafted change impact assessment documents are created and assure that quality documents are properly redlined, and in- process revisions are properly controlled prior to approval.
• Accurately conduct a detailed review of changes for documents prior to submission to supervisor/approver(s) to ensure that all necessary documents for routing change request are in place prior to routing for approval.
• Ensure that documentation is appropriate, justified and approved by responsible functional areas in accordance with the timeline and in compliance to established procedures.
• Qualifications Education Bachelor’s degree in life sciences.