What are the responsibilities and job description for the Technical Writer - I position at TekOne IT Services Pvt. Ltd.?
Role: Technical Writer - I
Location: San Diego, CA
Duration: 6 Months on W2
Job Description
Location: San Diego, CA
Duration: 6 Months on W2
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.
- 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 for primarily for device master records and gather 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.
- 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.
- Bachelor’s degree in life sciences or Bachelors 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.
