Technical Writer

Target PR Range: $55–$65/hr DOE

About the role

The Technical Writer will be a member of the Manufacturing organization responsible for the creation, revision, formatting, and maintenance of GMP documentation supporting Drug Substance and Central Services manufacturing operations.

Responsibilities

• Ensure high standards of cGMP documentation practices are always adhered to.
• Author, edit, format, revise, and maintain SOPs, batch records, work instructions, forms, templates, and logbooks.
• Coordinate document reviews and approvals through the document management system.
• Manage document lifecycle activities including creation, revision, issuance, periodic review, and archival.
• Ensure high standards of housekeeping are adhered to at all times.
• Drive closure of assigned internal/regulatory audit items as required.
• Represent manufacturing in Project team meetings as required.
• Ensure effective liaison and communication with other departments, maintaining good relations at all times.
• Ensure that the appropriate safety policies and systems are adhered to in the GTMF suite.
• Ensure that objectives given are met in the appropriate agreed-to timescale.

Requirements

• 2–3 years of experience with Document management systems preferred.
• Experience with CAPA preferred.
• Team-working skills and communication skills.
• Independently motivated and detail-oriented with good problem-solving ability.
• Ability to read, write, and understand English, and be proficient in Microsoft (Excel, Word, Outlook).