Job Description

Title: ADQC Technical Writer

This position can be full time remote, 1-2 on site visits/month

Contract duration: 6 months, with possible extension

Day Shift, Monday to Friday, 8:00am to 4:30pm

This position is a 6 month position supporting analytical transfer documentation in the Analytical Development and Quality Control department. This position supports the Analytical Development team in the cell and gene therapy division of Genentech, authoring and reviewing documents such as method validation protocols, reports, test methods, and SOPs, while ensuring GMP standards are met.

You are responsible for working closely with relevant stakeholders as well as cross-site SMEs to draft, review and approve technical documents.

Job Duties/Responsibilities:

Author and edit a wide range of technical documents, including but not limited to:

• Standard Operating Procedures (SOPs)
• Validation protocols and reports for analytical methods
• Test methods and work instructions
• Change control records
• Ensure all documentation adheres to strict regulatory guidelines (e.g., FDA, EMA, ICH, cGMP) company policies, and quality standards.
• Translate complex scientific and technical information into clear, concise, and user-friendly content for various audiences, including scientists, technicians, and quality assurance personnel.
• Manage the document lifecycle, including drafting, review cycles, approval, revision, and archival within an electronic document management system (EDMS).
• Collaborate closely with Subject Matter Experts (SMEs), such as scientists and lab managers, to gather information and ensure the technical accuracy of all content.
• Facilitate document review meetings and incorporate feedback from stakeholders and subject matter experts.
• Ensure a consistent and predictable approach to documentation, maintaining a unified style, terminology, and format across all documents.
• Review documents for scientific and technical accuracy, clarity, and adherence to Good Manufacturing Practice (GMP) standards.

Job Qualifications:

• Bachelor’s degree, preferably in Chemistry, Biochemistry, or Molecular Biology
• Demonstrated experience with scientific and/or technical document writing
• Excellent verbal and written communication skills, with the ability to effectively present information

You will stand out if you have:

• 1+ years of relevant QC experience.
• 3-5 years of experience working in the pharmaceutical or biopharmaceutical industry.
• A solid understanding of cGMPs or similar regulations.
• A strong aptitude for interpreting and implementing Quality standards.
• Strong problem-solving capabilities.
• Experience writing validation and qualification reports.

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