Documentation Specialist

*This position is 100% on-site work*

*This position is a 3-6 month contract*

• Collaborate with subject matter experts (SMEs) from various departments including production, quality assurance, maintenance, and safety to gather information on existing processes and procedures.
• Develop clear and concise SOPs that document step-by-step instructions for each aspect of the manufacturing process, including equipment operation, material handling, quality checks, and troubleshooting procedures.
• Create SWIs with organized information in a logical and easy-to-follow format, including text, diagrams, and illustrations as necessary.
• Ensure that all SOPs and SWIs comply with regulatory standards and industry best practices.
• Review and update existing SOPs to reflect any changes in processes, equipment, or regulations.
• Review and update existing SWIs to ensure accurate instruction and explanation of all required steps.
• Identify potential hazards, including physical, chemical, biological, ergonomic, and psychosocial factors, associated with each job task.
• Assess the severity and likelihood of potential hazards and prioritize them based on risk level.
• Participate in internal and external audits to ensure compliance with SOPs, SWIs, JHAs and regulatory requirements.
• Maintain accurate documentation of all SOPs, SWI, JHA, and related materials in a centralized database or document management system.
• Continuously monitor manufacturing operations and gather feedback from employees to identify opportunities for further documentation improvement.

• Bachelor's degree in Engineering, Industrial Technology, or a related field.
• Previous experience in a manufacturing operations or process engineering position preferred.
• Excellent written and verbal communication skills, with the ability to convey technical information clearly and effectively.
• Exceptional attention to detail and accuracy in documentation.
• Proficiency in Microsoft Office Suite and experience with document management systems.
• Commitment to upholding safety standards and promoting a culture of continuous improvement.

Additional Skills

• Experience with Lean Six Sigma or other continuous improvement methodologies.
• Familiarity with electronic batch record (EBR) systems or manufacturing execution systems (MES).
• Knowledge of Good Manufacturing Practices (GMP) and/or Good Documentation Practices. (GDP)