Pharma QA Engineer: Regulatory Documentation & Support

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

Benefits offered by this job

Healthcare

Life insurance

Retirement plan

Job summary

Cambrex Charles City, IA is seeking a Quality Assurance Engineer to serve as the liaison between our generic clients and our site for regulatory documentation, reviews of stability data, and assessment of analytical method reports. Responsibilities include reviewing customer specifications, coordinating CEPs and filings, supporting regulatory submissions, and compiling Annual Product Quality Reviews.

A BS/BA and 3–5 years in a cGMP environment are required; excellent English communication and

Qualifications

• BS or BA degree in a science field.
• 3–5 years of relevant experience in a cGMP environment.
• Experience at a commercial pharmaceutical manufacturing facility preferred.

Responsibilities

• Serve as QA liaison to review customer specifications, stability data, and statements of compliance.
• Review company technical documents and regulatory filings coordination (CEPs, Letters of Authorization, EDMF/CDMF).
• Coordinate regulatory submissions and assess regulatory impact of changes.
• Compile and author Annual Product Quality Reviews.
• Ensure compliance with DEA, EPA, FDA and cGMP, and safety rules.

Skills

Written and oral communication in Eng

Critical thinking

Interpersonal and leadership

Education

BS or BA

Job description

Cambrex Charles City, IA is seeking a Quality Assurance Engineer to serve as the liaison between our generic clients and our site for regulatory documentation, reviews of stability data, and assessment of analytical method reports. Responsibilities include reviewing customer specifications, coordinating CEPs and filings, supporting regulatory submissions, and compiling Annual Product Quality Reviews.

A BS/BA and 3–5 years in a cGMP environment are required; excellent English communication and