Technical Writer

Technical Writer Overview

• The Technical Writer will support manufacturing operations by creating and maintaining GMP documentation.
• Ensure adherence to high standards of cGMP documentation practices at all times.
• Collaborate with cross-functional teams to ensure accurate and timely documentation.
• Contribute to the success of drug substance and central services manufacturing operations.
• Utilize document management systems to coordinate reviews and approvals effectively.
• Maintain a high level of organization and attention to detail in all tasks.
• This hybrid role offers flexibility and the opportunity to work in a dynamic environment.

Technical Writer Key Responsibilities & Duties

• Author, edit, format, and revise SOPs, batch records, and related documents.
• Manage the lifecycle of GMP documentation, including creation, issuance, and archival.
• Coordinate document reviews and approvals using document management systems.
• Ensure compliance with safety policies and systems within the manufacturing suite.
• Represent manufacturing in project team meetings as required.
• Drive closure of assigned internal and regulatory audit items.
• Maintain effective communication and collaboration with other departments.
• Adhere to housekeeping standards and ensure objectives are met within agreed timelines.

Technical Writer Job Requirements

• Bachelor of Science (BS) degree required.
• 2-3 years of experience with document management systems preferred.
• Experience with CAPA systems is advantageous.
• Proficiency in Microsoft Office Suite (Excel, Word, Outlook).
• Strong team-working and communication skills.
• Detail-oriented and independently motivated with strong problem-solving abilities.
• Ability to read, write, and understand English fluently.
• Familiarity with GMP documentation practices and standards.