Sr. Technical Writer

Fresenius Kabi • Wilson, NC

1d

About The Position

Independently investigates process deviations and customer complaints, determines root causes, and initiates corrective and preventative actions to address Quality deficiencies. Provides proactive corrections based on trends to reduce the risk of repeat incidents that could lead to Product Discards, Field Actions, or Recalls. Manages assigned investigations from initiation through completion with minimal supervision, applying risk assessment and root-cause analysis to evaluate impacts on products, processes, and patient health and safety. Provides technical expertise and communicates findings and recommendations to site colleagues and senior management.

Responsibilities

• Ensure compliance with relevant Standard Operating Procedures while collecting and analyzing internal and external information to assess the impact of process deviations and complaints on products, processes, and patient health and safety.
• Gather information from necessary internal and external sources to evaluate effects on previously manufactured product and risks to future operations.
• Prepare and analyze manufacturing and laboratory analytical historical data, use methodical root-cause analysis tools, and communicate root causes to senior management.
• Assess manufacturing or analytical environments and recommend appropriate corrective and preventative actions using industry-accepted analytical tools.
• Provide technical expertise to ensure investigation corrective and preventative 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.
• Independently conduct deviation and complaint investigations under procedure-driven guidelines and make decisions affecting patient health and safety.
• Provide technical assistance to area supervisors, managers, and technical writers in solving complex problems.
• Maintain deadlines, monitor and manage extension needs for Subsequent Actions and Investigations, and meet closure targets or provide adequate justification when commitments are not met.
• Fulfill commitments agreed upon with department management.
• Comply with company documents, programs, and activities related to Health, Safety, Environment, Energy, and the Quality Management System, according to the role's responsibilities.
• Perform other tasks as directed or requested by management or site leadership.

Benefits

• 401(k) plan with company contributions
• Paid vacation, holidays, and personal days
• Employee assistance program
• Medical coverage
• Prescription drug coverage
• Dental coverage
• Vision coverage
• Life insurance
• Disability coverage
• Wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed