Responsibilities:

• Excellent employment opportunity for a Technical Writer in the Fremont, CA area.
• May be responsible for coordinating the display of graphics and the production of the document.
• Writes a variety of technical articles, reports, brochures, and/or manuals for documentation for a wide range of uses.
• Paper batch record authoring/revision/template creation CAPA execution/follow-up for doc revisions SOP revisions/authoring Update/create training documents w/ training specialist.

Experience:

• Bachelor’s Degree Technical writing certification preferred.
• Minimum 2 years relevant experience in the Pharmaceutical, Biotech, Medical Device, or other regulated environment
• Familiar with a variety of the field’s concepts, practices, and procedures.
• Strong technical writing skills
• Experience authoring and revising cGMP documentation for commercial operations.
• Advanced proficiency in MS Word
• Working knowledge of cGMP document control systems Intermediate knowledge of biopharmaceutical operations preferred
• Required Skills: CONTROL SYSTEMS, DOCUMENT CONTROL, CGMP, OPERATIONS, BIOPHARMACEUTICAL
• Additional Skills: MEDICAL DEVICE, WRITING SKILLS, SOP, DOCUMENTATION, BATCH RECORD, CORRECTIVE AND PREVENTIVE ACTION, MICROSOFT WORD