Quality Manufacturing Technical Writer

Quality Manufacturing Technical Writer

This role supports highly regulated pharmaceutical manufacturing environments by developing clear, compliant, and technically accurate documentation across critical quality and production systems. The position plays a key role in translating complex manufacturing, quality, and regulatory processes into structured documentation that ensures operational consistency and inspection readiness. Working across multiple functional areas, the Technical Writer contributes to improving data integrity, strengthening quality systems, and supporting compliance in GMP environments. The role is embedded within a collaborative consulting setting, engaging with experts across manufacturing, laboratory operations, and quality assurance. It offers exposure to diverse pharmaceutical production systems and lifecycle stages, from facilities and utilities to contamination control. This is a detail-driven position where precision, regulatory understanding, and clarity of communication directly support patient safety and product quality.

Accountabilities:

• Develop, revise, and maintain technical and quality documentation supporting pharmaceutical manufacturing processes across GMP-regulated environments.
• Translate complex operational inputs from manufacturing, laboratory, and quality teams into clear, structured, and compliant documentation.
• Support documentation needs across key workstreams including contamination control, environmental monitoring, production controls, data integrity, facilities, utilities, and laboratory controls.
• Ensure documentation aligns with regulatory expectations, internal quality systems, and industry best practices.
• Collaborate with cross-functional stakeholders in quality assurance, manufacturing, and compliance to gather requirements and validate technical accuracy.
• Contribute to continuous improvement initiatives by identifying gaps in documentation processes and enhancing standardization and clarity.
• Support audit and inspection readiness activities by ensuring documentation is complete, consistent, and up to date.

Requirements:

• Experience in technical writing within pharmaceutical, biotech, med device, or other regulated manufacturing environments.
• Strong understanding of GMP principles and quality systems within pharmaceutical manufacturing operations.
• Ability to interpret complex technical information across manufacturing, laboratory, and quality functions and translate it into clear documentation.
• Familiarity with areas such as contamination control, environmental monitoring, data integrity, production systems, or laboratory operations.
• Excellent written communication skills with strong attention to detail and documentation accuracy.
• Ability to work independently while coordinating effectively with cross-functional stakeholders.
• Strong organizational skills and ability to manage multiple documentation streams simultaneously in a regulated environment.
• Prior consulting experience or exposure to multi-client environments is a plus.

Benefits:

• Competitive compensation aligned with experience and expertise in regulated industries.
• Remote working opportunities with flexibility depending on project and client needs.
• Exposure to leading pharmaceutical, biotech, and medical device manufacturing environments.
• Opportunity to contribute to high-impact quality and compliance initiatives supporting patient safety.
• Collaborative and inclusive work culture emphasizing diversity, equity, and professional growth.
• Engagement across multiple technical workstreams providing broad exposure to GMP operations.
• Hybrid working options may be available depending on location and client proximity.