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.

Salary Range: $73,614–$103,528. Eligible to participate in a bonus plan with a target of 6% of the base salary.

• 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 of each process deviation and complaint 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 and 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.
• Communicate the root cause to senior management and advise on appropriate corrective/preventative actions to mitigate quality deficiencies identified in the investigative process.
• Provide technical expertise to the site to ensure that corrective and preventative actions are complete, thorough, accurate, and timely.
• Update and maintain all related enterprise quality management system records in compliance with governing procedures and policies as they relate to investigations.
• Perform trend analysis and work independently to comply with procedure‑driven guidelines for deviation and complaint investigations.
• Make decisions that directly affect patient health and safety and demonstrate strong technical skills, providing assistance to supervisors, managers, and technical writers to solve complex problems.
• Ensure deadlines are maintained and closely monitor the need for extensions to maintain compliance.
• Accountable for commitments agreed upon with department management and required to comply with closure targets.
• Perform any other tasks as directed or requested by management or site leadership.

• 401(k) plan with company contributions
• Paid vacation, holiday and personal days
• Employee assistance program
• Health benefits, including medical, prescription drug, dental and vision coverage
• Life insurance
• Disability insurance
• Wellness program

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.