Technical Writer

Fresenius Kabi USA•Melrose Park, IL

69d•$70,000 - $85,000

About The Position

The Technical Writer supports a key site department, such as Production, Packaging, Quality Assurance, Tech Transfer, or Engineering, by independently managing process deviation and customer complaint investigations from initiation through completion. The role determines root causes and initiates corrective and preventative actions to address quality deficiencies. It also identifies trends and recommends proactive corrections to reduce repeat incidents that could lead to product discards, field actions, or recalls. The position works with minimal supervision and makes decisions that can directly affect patient health and safety. The incumbent gathers and analyzes information from internal and external sources to assess the impact of deviations and complaints on products, processes, patient health and safety, previously manufactured product, and future operations. They analyze manufacturing and laboratory historical data, use accepted root-cause analysis tools, communicate findings to senior management, and advise on appropriate corrective and preventative actions. The role provides technical expertise and assistance to site personnel, maintains investigation-related records in accordance with governing procedures and policies, performs trend analysis, and monitors deadlines and extensions for investigations and subsequent actions. Employees are responsible for complying with company documents, programs, and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems. The position offers a stated salary range of $70,000–$85,000 and eligibility to participate in a bonus plan with a 6% target of base salary. Final pay depends on factors including experience, education, knowledge, skills, and abilities. Employment is at-will; joining the company does not create a guaranteed or permanent employment arrangement.

Requirements

Bachelor of Arts or Bachelor of Science degree in a science field, such as Biology, Microbiology, Chemistry, or Pharmacy, or an equivalent combination of education and experience.
Minimum of 3 years of pharmaceutical or related work experience, with emphasis on current Good Manufacturing Practices.
Strong deductive and inductive critical-thinking skills.
Advanced writing skills.
Strong interpersonal, written, and verbal communication skills.
Ability to interface positively with regulatory agencies, vendors, and company departments.
Good knowledge of Microsoft Office programs, including Word and Excel.
Ability to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English.

Responsibilities

Ensure compliance with relevant Standard Operating Procedures while gathering, analyzing, and applying information to assess the impact and risk of process deviations and complaints on products, processes, and patient health and safety.
Gather information from necessary internal and external sources to evaluate deviation impacts on previously manufactured product and risks to future operations.
Prepare and analyze historical manufacturing and laboratory analytical data; use methodical root-cause analysis tools and communicate root causes to senior management.
Assess manufacturing or analytical environments and advise senior management on 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 investigation-related materials in compliance with governing procedures and policies, and perform trend analysis.
Independently manage deviation and complaint investigations according to procedure-driven guidelines and make decisions that directly affect patient health and safety.
Provide technical assistance to area supervisors or managers in solving complex problems.
Maintain deadlines and monitor whether extensions are needed for subsequent actions and investigations to ensure compliance.
Comply with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management Systems.