Sr. Technical Writer

Fresenius Kabi•Wilson, NC

19h

About The Position

Independently investigates process deviations and customer complaints, determines root causes, and initiates corrective and preventive actions to address Quality deficiencies. Identifies trends and recommends proactive corrections to reduce repeat incidents that could lead to Product Discards, Field Actions, or Recalls. The position manages assigned investigations from initiation through completion with minimal supervision and makes decisions that directly affect patient health and safety. The role assesses the risk and impact of deviations and complaints on products, processes, and patient health and safety. It gathers information from internal and external sources, evaluates effects on previously manufactured products and future operations, analyzes manufacturing and laboratory historical data, and communicates findings and root causes to senior management. The incumbent provides technical expertise and advice on appropriate corrective and preventive actions, maintains investigation-related enterprise quality management systems, performs trend analysis, and ensures investigations and actions are complete, accurate, timely, and compliant with applicable procedures and policies. The position also supports supervisors, managers, and technical writers in solving complex problems, monitors investigation deadlines and extensions, and remains accountable for departmental commitments and closure targets. Employees are responsible for compliance with company requirements related to Health, Safety, Environment, Energy, and the Quality Management System. Other duties may be assigned by management or site leadership.

Requirements

Ability to manage assigned investigations independently with minimal supervision, from initiation to completion.
Strong technical skills and ability to solve complex problems.
Ability to gather, analyze, and apply information from internal and external sources.
Ability to use methodical root-cause analysis tools and industry-accepted analytical tools.
Ability to assess manufacturing or analytical environments and recommend corrective and preventive actions.
Ability to communicate investigation findings and root causes to senior management.
Ability to meet deadlines, comply with closure targets, and provide adequate justification when commitments are not met.
Compliance with relevant Standard Operating Procedures and company policies.

Responsibilities

Investigate process deviations and customer complaints, determine root causes, and initiate corrective and preventive actions.
Assess the risks and impacts of deviations and complaints on products, processes, patient health, and patient safety.
Gather information from internal and external sources to evaluate impacts on previously manufactured products and future operations.
Prepare and analyze manufacturing and laboratory analytical historical data using root-cause analysis tools.
Communicate investigation root causes to senior management.
Independently assess manufacturing or analytical environments and advise senior management on corrective and preventive actions using industry-accepted analytical tools.
Provide technical expertise to ensure investigation actions are complete, thorough, accurate, and timely.
Update and maintain enterprise quality management systems in accordance with governing procedures and policies, and perform trend analysis.
Comply with procedure-driven guidelines for deviation and complaint investigations and make decisions affecting patient health and safety.
Provide technical assistance to area supervisors, managers, and technical writers to solve complex problems.
Maintain deadlines, monitor the need for extensions, meet closure targets, and provide justification when commitments are not met.
Comply with company documents, programs, and activities related to Health, Safety, Environment, Energy, and the Quality Management System.
Perform other tasks as directed or requested by management or site leadership.