Pharma QA Engineer: Regulatory & Documentation

Cambrex; Charles City (IA); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Retirement planning

Job summary

Cambrex in Charles City, IA is seeking a Quality Assurance Engineer to serve as the liaison between our clients and the site, handling regulatory documentation requests and acting as a technical reviewer for stability, analytical methods, and batch records.

You will review customer specifications, support regulatory submissions, coordinate CEP/EDMF filings, and contribute to annual product quality reviews while ensuring compliance with DEA, EPA, FDA and cGMP.

Qualifications

• Must communicate in English, both written and spoken.
• Demonstrated critical thinking and problem-solving skills.
• Strong interpersonal and leadership abilities.

Responsibilities

• Serve as QA liaison to supply data for regulatory needs.
• Review customer specifications and stability data for compliance.
• Coordinate CEP, EDMF/MAA filings and customer inquiries.
• Review change controls for regulatory impact and compliance.
• Prepare and write Annual Product Quality Reviews.

Skills

Written & verbal comms

Critical thinking

Interpersonal leadership

Education

BS or BA

Job description

Cambrex in Charles City, IA is seeking a Quality Assurance Engineer to serve as the liaison between our clients and the site, handling regulatory documentation requests and acting as a technical reviewer for stability, analytical methods, and batch records.

You will review customer specifications, support regulatory submissions, coordinate CEP/EDMF filings, and contribute to annual product quality reviews while ensuring compliance with DEA, EPA, FDA and cGMP.