• Author reports, procedures and other documents in support of the Quality department.
• Assist multiple departments in the preparation of a variety of technical documents such as procedures, data summaries, protocols, validation and development reports, analytical method and process descriptions and posters and presentations for dissemination.
• Perform and document investigations, CAPA's and effectiveness checks.
• Organize, review and interpret statistical data and information from subject SME's.
• Manage multiple projects simultaneously while interacting with various departments, vendors, contractors and clients.
• Perform other duties as assigned by Quality management.
• BS/BA in Biochemistry, Biology, Chemistry or related scientific field
• 3+ years of writing experience in a biopharmaceutical or biotechnology industry.
• Familiarity with ICH and FDA guidelines, GMP regulations and quality compliance requirements
• Must have excellent technical writing skills and graphics, editing, formatting and organization skills.
• Excellent scientific and technical writing abilities and advanced computer skills.
• Must be able to present writing samples from publications, preferably as first author.
If interested, feel free to contact Sal @ (562)495-3200 x3 or email updated resumes to firstname.lastname@example.org