Sr. Technical Writer

Job Summary

Independently responsible for the efficient and thorough investigation of process deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, the issuance of Product Discards, Field Actions, or Recalls. The position requires working with minimal supervision to manage assigned investigations from initiation to completion.

Responsibilities

• Ensure compliance with relevant Standard Operating Procedures while gathering, analyzing and applying information from internal and external sources to perform a risk assessment of the impact each process deviation and complaint has on the product, process, and patient health and safety.
• Gather information from all necessary internal and external sources to evaluate the impact of the deviation on previously manufactured product, as well as the risk to future operations.
• Prepare and analyze manufacturing and laboratory analytical historical data and use methodical root-cause analysis tools to determine root causes and effectively communicate the root cause to senior management.
• Assess the manufacturing or analytical environment, independently conceive, and advise senior management on appropriate corrective/preventative actions designed 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 that deadlines are maintained and closely monitor the need for extensions to be administered in relation to Subsequent Actions and Investigations in order to maintain compliance in this area.
• Accountable for commitments agreed upon with department management; required to comply with closure targets and provide adequate justification if commitments are not met.
• Ensure compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per roles and responsibilities.
• Any other task as directed or requested by management or site leadership.