Pharma Technical Writer – Investigations & Quality Compliance

Fresenius; Melrose Park (IL); Hybrid; USD 70,000 - 85,000; Full time

Benefits offered by this job

401(k) with company contributions

Health, dental and vision coverage

Paid vacation and holidays

Employee assistance program

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL, is seeking a quality investigations professional to independently conduct root-cause analyses of deviations and complaints, initiate CAPAs, and ensure compliance with GMP. You will assess risk to product, process, and patient health, and communicate findings to senior management.

The role requires a BA/BS in science and 3+ years in pharma, plus strong writing and interpersonal communication.

Qualifications

• BA/BS in science field (biology, microbiology, chemistry, pharmacy, etc.).
• Minimum 3 years of pharmaceutical or related work experience with GMP emphasis.
• Advanced writing skills and strong interpersonal, written, and verbal communication.

Responsibilities

• Ensure compliance with SOPs while performing risk assessments on deviations and complaints.
• Gather information from internal/external sources to evaluate impact on product and patient safety.
• Analyze historical data and use root-cause analysis tools to identify and communicate root causes to senior management.
• Advise senior management on corrective/preventive actions to mitigate quality deficiencies.
• Provide technical support to ensure investigations and actions are complete, accurate, and timely.
• Maintain documentation and perform trend analysis in compliance with procedures.

Skills

Critical thinking

Writing skills

Communication skills

Education

BA/BS in science

Tools

MS Office

Job description

Fresenius Kabi in Melrose Park, IL, is seeking a quality investigations professional to independently conduct root-cause analyses of deviations and complaints, initiate CAPAs, and ensure compliance with GMP. You will assess risk to product, process, and patient health, and communicate findings to senior management.

The role requires a BA/BS in science and 3+ years in pharma, plus strong writing and interpersonal communication.