SR. TECHNICAL WRITER

Fresenius Kabi USA•Wilson, NC

1d•$73,614 - $103,528

About The Position

Independently investigates process deviations and customer complaints, determines root causes, and initiates corrective and preventative actions to address Quality deficiencies. The role also identifies trends and recommends proactive corrections to reduce the likelihood of 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 may directly affect patient health and safety. The incumbent assesses the impact and risk of deviations and complaints to products, processes, and patient health and safety; evaluates effects on previously manufactured product and future operations; analyzes manufacturing and laboratory historical data; and communicates root causes and recommended actions to senior management. The position provides technical expertise to the site, supports area supervisors, managers, and technical writers in resolving complex problems, maintains investigation records in enterprise quality management systems, performs trend analysis, and ensures investigation actions and deadlines meet procedural and compliance expectations.

Requirements

Ability to independently manage assigned investigations from initiation to completion with minimal supervision.
Strong technical skills.
Ability to investigate process deviations and customer complaints, determine root causes, and initiate corrective and preventative actions.
Ability to gather, analyze, and apply information from internal and external sources and conduct risk assessments.
Ability to analyze manufacturing and laboratory historical data and apply root-cause analysis tools.
Ability to provide technical expertise and communicate investigative findings and recommendations to senior management.
Ability to manage deadlines, closure targets, and investigation documentation in accordance with procedures and policies.

Responsibilities

Ensure compliance with relevant Standard Operating Procedures while gathering and applying internal and external information to assess the impact of process deviations and complaints on products, processes, and patient health and safety.
Gather information needed to evaluate the impact of deviations on previously manufactured product and risks to future operations.
Prepare and analyze manufacturing and laboratory analytical historical data; use root-cause analysis tools to determine causes and communicate findings to senior management.
Assess manufacturing or analytical environments and advise senior management on corrective and preventative actions to mitigate Quality deficiencies.
Provide technical expertise to ensure investigation corrective and preventative actions are complete, thorough, accurate, and timely.
Update and maintain related enterprise quality management systems in compliance with governing procedures and policies, and perform trend analysis.
Independently conduct deviation and complaint investigations in accordance with procedure-driven guidelines and make decisions affecting patient health and safety.
Provide technical assistance to area supervisors, managers, and technical writers to solve complex problems.
Maintain deadlines and monitor the need for extensions related to Subsequent Actions and Investigations.
Meet commitments and closure targets agreed upon with department management, 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.