Fresenius Kabi USA, LLC is hiring: Technical Writer in Wilson

Job Summary

Works with supervision and senior technical writers to investigate deviations and customer complaints, determine root causes, and initiate corrective and preventative actions to address quality deficiencies efficiently and thoroughly. Responsible for recommending proactive corrections based on trend analysis to minimize the risk of product discards, field actions, or recalls. The position requires working with moderate supervision to manage investigations from initiation to completion.

Responsibilities

• Ensure compliance with relevant SOPs while gathering, analyzing, and applying information from internal and external sources for risk assessment of deviations and complaints on product, process, and patient safety.
• Gather information during investigations to evaluate the impact on previously manufactured products and future operations.
• Prepare and analyze historical manufacturing and laboratory data, using root-cause analysis tools to determine causes and communicate findings to senior management.
• Collaborate with senior technical writers and supervision for root cause analysis and corrective action proposals.
• Maintain enterprise quality management systems in compliance with governing procedures, perform trend analysis.
• Work independently to ensure investigations comply with procedural guidelines, supporting management decisions affecting patient health and safety.
• Demonstrate strong technical skills and ensure deadlines are met, requesting extensions when necessary to maintain compliance.
• Fulfill commitments with department management, providing justification if deadlines are missed.
• Ensure compliance with health, safety, environment, energy, and quality management systems related to your role.
• Perform other tasks as directed by management or site leadership.

Requirements

• Bachelor's degree with 1-2 years of experience in pharmaceutical manufacturing or cGMP environment.
• Associate's degree with 5+ years of experience in pharmaceutical manufacturing or cGMP environment.
• Working knowledge of GMP, EU, GLP, FDA trends, and guidelines.
• Excellent verbal and written communication skills.
• Strong deductive and inductive critical thinking skills.
• Strong interpersonal and communication skills to interface with regulatory agencies, vendors, and departments. Proficiency in MS Office, including Word and Excel.

Additional Information

We offer an excellent salary and benefits package, including medical, dental, vision coverage, life insurance, disability, 401K with company contribution, and wellness programs.

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