Sr. Technical Writer

Responsibilities

• Ensure compliance with relevant Standard Operating Procedures, gather, analyze, and apply information from internal and external sources to perform a risk assessment of the impact of process deviations and complaints.
• Gather information from all necessary internal and external sources to evaluate the impact of the deviation on previously manufactured product and the risk to future operations.
• Prepare and analyze manufacturing and laboratory analytical historical data, use root-cause analysis tools to determine root causes, and communicate these findings to senior management.
• Conceive and advise on appropriate corrective/preventative actions to mitigate Quality deficiencies identified in the investigative process using industry accepted analytical tools.
• Provide technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely.
• Update and maintain all related enterprise quality management systems in compliance with various governing procedures and policies as they relate to investigations and perform trend analysis.
• Work independently to comply with procedure-driven guidelines relating to Deviation and complaint investigations and make decisions that directly affect patient health and safety.
• Demonstrate strong technical skills; provide technical assistance to area supervisors, managers, and technical writers to solve complex problems.
• Ensure deadlines are maintained and closely monitor the need for extensions to be administered in relation to Subsequent Actions and Investigations to maintain compliance in this area.
• Accountable for commitments agreed upon with department management and provide adequate justification if commitments are not met.
• Ensure compliance with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management System as per their roles and responsibilities.

Qualifications

Requires working with minimal supervision to manage assigned investigations from initiation to completion. Strong technical skills are required, along with the ability to work independently and make decisions that affect patient health and safety. Knowledge of industry accepted analytical tools and procedures is essential. Experience in quality management systems and process deviations is preferred.