Lead Technical Writer, Quality Investigations

Fresenius Kabi USA, LLC; Grandyle Village (NY); On-site; USD 74,000 - 103,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k) with company contribution

Wellness program

Job summary

Fresenius Kabi USA, LLC is seeking a dedicated investigator to lead process deviation and customer complaint investigations from initiation to completion. You will perform root-cause analyses, determine impacts on product safety, and drive corrective actions while maintaining strict regulatory compliance.

The role requires strong technical writing, critical thinking, and collaboration with multiple departments.

Qualifications

• BA/BS Degree in science field or equivalent.
• 3–5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices.
• Strong deductive and inductive critical thinking skills.
• Advanced technical writing skills.
• Candidate must possess strong interpersonal, written, and verbal communication skills.
• Interface positively with Regulatory Agencies, vendors, and company departments. Proficiency with MS Office (Word, Excel).
• English as primary business language; able to read and write all policies and training materials in English.

Responsibilities

• Perform risk assessment of deviations and complaints and determine impact on product and patient safety.
• Collect information from internal and external sources to evaluate deviation impact on past and future operations.
• Use root-cause analysis tools to identify root causes and communicate findings to senior management.
• Advise management on corrective/preventative actions to mitigate quality deficiencies.
• Provide technical expertise to ensure investigations are thorough, accurate, and timely.
• Maintain and analyze trend data in enterprise quality systems and ensure regulatory compliance.
• Work independently under procedure-driven guidelines for deviation investigations and enforce deadlines.
• Support area supervisors and write teams to solve complex problems.

Skills

Critical thinking

Technical writing

Interpersonal communication

MS Office

English proficiency

Education

BA/BS in science

Tools

MS Word

MS Excel

Job description

Fresenius Kabi USA, LLC is seeking a dedicated investigator to lead process deviation and customer complaint investigations from initiation to completion. You will perform root-cause analyses, determine impacts on product safety, and drive corrective actions while maintaining strict regulatory compliance.

The role requires strong technical writing, critical thinking, and collaboration with multiple departments.