Technical Writer

Quality Technical Writer and Training Specialist

Key Responsibilities:

Documentation Development

• Create Highly detailed, clear step-by-step guides – one point lesson visual standards, user friendly work instructions and standard operating procedures that explain exactly how to execute a specific production task to ensure accuracy and efficiency across all manufacturing operations.
• Managing learning and training delivery – designing and hosting virtual and/or in-person training sessions for all employees at every level.
• Collaborate and assist in the development and maintenance of quality work instructions utilized by each department to complete Quality SOPs, WI and forms.
• Regularly review and update existing documentation to reflect process changes ensuring version control improvements, or regulatory compliance updates and accuracy across all materials.
• Work closely with Manufacturing as the primary technical subject-matter experts to gather and incorporate information into production documents.
• Partner with Quality Assurance teams to develop, review, and validate documentation supporting product quality initiatives.
• Coordinate with production staff to validate that work instructions are accurate, clear, and operationally effective across entire operations.

• Train production staff on new and updated documentation and standards to ensure proper implementation and consistent execution.
• Perform regular audits of production documentation to verify compliance with established standards and identify gaps.
• Support compliance efforts with applicable regulatory requirements.
• Audit-Ready document control.
• Identify opportunities for improving documentation processes and implement best practices to enhance productivity and quality.
• Apply lessons learned from audits, staff feedback, and process reviews to continuously elevate documentation quality.
• Contribute to a culture of quality and continuous improvement by championing clear, accurate, and accessible documentation.

• Bachelor's Degree in Technical Writing, Journalism, Education, Communications, Engineering, Manufacturing, Industrial Engineering, Business Administration, Information Technology, or a related field.
• Strong technical writing skills with meticulous attention to detail.
• Ability to collaborate effectively across engineering, manufacturing, and quality functions.
• Strong verbal and written communication skills with the ability to effectively engage cross-functional teams, deliver training, and communicate complex information clearly to diverse audiences.
• Possesses strong interpersonal and written communication skills (verbal and written) suitable for cross-functional audiences.
• Validate quality documents while ensuring version control and compliance.
• Works with digital controls (IT) where documents are generated and stored electronically.

• Primary experience has been in manufacturing and quality-regulated operations, bio-pharmaceutical, GMP, and FDA environments.
• Experience with document control systems supporting manufacturing, safety, maintenance, information technology (IT), wastewater treatment, utilities, procurement, receiving, shipping, and distribution functions.
• Certification or training in technical writing or quality management (e.g., ISO 9001, HACCP, FDA, GMP).

• Technical Writing & Documentation
• Attention to Detail
• Cross-functional Collaboration
• Process Orientation
• Training & Knowledge Transfer
• Quality Mindset
• Clear Communication

• Travel up to approximately 10% annually.