Technical Writer

About the position

The position involves writing Standard Operating Procedures (SOPs), change controls, deviations, non-conforming material reports, and training materials based on validated processes. The individual will be responsible for determining root causes and authoring corrective actions associated with deviations and non-conforming material reports (NCMRs). The role requires designing, developing, and implementing customized technical documents for various teams, gathering information about needs, objectives, functions, features, and requirements. The work assignments will increase in complexity, performed under moderate supervision with some latitude for independent judgment. The candidate will need to transform technical and scientific concepts into simple language for average readers.

Responsibilities

• Creation, writing, and/or editing of procedures, SOPs, deviations, non-conforming material reports, and change control documents.
• Coordinating deviation and non-conformance investigations.
• Working with subject matter experts to assign root cause and corrective actions for deviations and NCMRs.
• Identifying documentation needs across maintenance, production, quality, and engineering teams.
• Designing and managing independent projects, communicating project updates to key team members.
• Interviewing production, maintenance, and engineering personnel to understand product technologies and production methods.
• Observing production and experimental activities to determine work instructions and documentation needs for training.
• Overseeing documents through the quality review process, ensuring approval by key subject matter experts and regulatory personnel.
• Illustrating technical or scientific concepts using photographs, drawings, sketches, diagrams, and charts.
• Studying drawings, specifications, and equipment to draft operating procedures, work instructions, or report justifications.
• Identifying trends in manufacturing processes based on reports related to product quality.
• Collaborating with other teams to track key information and create trend reports.
• Organizing material and completing writing assignments according to set standards.
• Editing, standardizing, or making changes to material prepared by others.
• Acting as the administrator for the facility calibration program.

Requirements

• Bachelor’s degree.
• At least two years’ experience in Medical, Pharmaceutical, Manufacturing, or other field under regulatory compliance.
• At least one year experience in Technical/Scientific Communication, Technical Writing, Regulatory Writing, or Medical Writing.
• Experience with Microsoft Excel and Microsoft Word.
• Experience with Adobe Acrobat Pro.

Nice-to-haves

• Knowledge of FDA GMP compliant manufacturing.
• Experience with Adobe InDesign, Photoshop, and/or Illustrator.
• Experience with Microsoft Visio.
• Experience in training, teaching, or general instructional design.

Benefits

• Health insurance
• Life and disability insurance
• 401(k) contributions
• Paid time off
• Access to Employee Assistance Program
• Access to Employee Resource Groups
• Access to Employee Service Corp