Sr. Technical Writer

Fresenius Kabi•Wilson, NC

About The Position

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.

Requirements

Efficient and thorough investigation of process deviations and customer complaints.
Determination of root cause.
Initiation of corrective/preventative actions.
Proactive corrections based on noted trends.
Minimize potential for repeat incidents.
Manage assigned investigations from initiation to completion.
Gathering, analyzing and applying information from internal and external sources.
Perform a risk assessment of the impact each process deviation and complaint has on the product, process, and patient health and safety.
Evaluate the impact of the deviation on previously manufactured product, as well as the risk to future operations.
Prepares and analyzes manufacturing and laboratory analytical historical data.
Uses methodical root-cause analysis tools to determine root causes.
Effectively communicates the root cause to senior management.
Properly assess the manufacturing or analytical environment.
Independently conceive and advise senior management on appropriate corrective/preventative actions.
Provides technical expertise to the site.
Ensures that investigation corrective and preventative actions are complete, thorough, accurate, and timely.
Updates and maintains all related enterprise quality management systems.
Performs trend analysis.
Works independently to comply with procedure driven guidelines relating to Deviation and complaint investigations.
Makes decisions that directly affect patient health and safety.
Demonstrates strong technical skills.
Provides technical assistance to area supervisors, managers, and technical writers to solve complex problems.
Ensures that deadlines are maintained.
Closely monitors the need for extensions to be administered in relation to Subsequent Actions and Investigations.
Accountable for commitments agreed upon with department management.
Required to comply with closure targets and provide adequate justification if commitments are not met.
Responsible for ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities.

Nice To Haves

Minimal supervision

Responsibilities

Responsible for ensuring compliance with relevant Standard Operating Procedures, while gathering, analyzing and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation and complaint has on the product, process, and patient health and safety.
As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufactured product, as well as the risk to future operations.
Prepares and analyzes manufacturing and laboratory analytical historical data and uses methodical root-cause analysis tools to determine root causes and effectively communicates the root cause to senior management.
The incumbent will need to properly 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.
The individual in the position provides technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely.
Updates and maintains all related enterprise quality management systems in compliance with various governing procedures and policies as they relate to investigations and performs trend analysis.
Works independently to comply with procedure driven guidelines relating to Deviation and complaint investigations and makes decisions that directly affect patient health and safety.
Demonstrates strong technical skills; provides technical assistance to area supervisors, managers, and technical writers to solve complex problems.
Ensures that deadlines are maintained and closely monitors 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.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities.
Any other task as directed or requested by management or site leadership.