Senior QA Engineer - Biopharma Quality & Compliance

Ferring Pharmaceuticals Inc.; Minneapolis (MN); On-site; USD 94,000 - 174,000; Full time

Job summary

Ferring Pharmaceuticals Inc. in Roseville, Minnesota, is seeking a Sr. Quality Engineer to provide QA support for biologics, ensuring compliance with cGMP and ICH/global regulations.

You will lead supplier quality, audits, CAPA, and quality system improvements across complex projects. The role calls for a Bachelor's degree in science with microbiology emphasis, 7+ years in GMP quality roles, and 3+ years in pharma.

Qualifications

• Bachelor's degree in science (chemistry, microbiology or biotechnology) with microbiology preferred.
• Minimum 7 years' experience in GMP Quality roles.
• Minimum 3 years' experience in pharmaceutical industry.
• Demonstrated experience in problem solving, root cause analysis and risk management methods.

Responsibilities

• Support supplier management process including supplier qualification, audits, SCARs and input to Quality Technical Agreements.
• Manage materials, parts, and services suppliers using a risk-based approach.
• Perform and support internal and external audits.
• Interface with internal departments and regulatory bodies regarding compliance needs.
• Review and approve Complaint, CAPA, Audit Findings and Deviation investigations to guide robust investigations.
• Improve processes and systems; update site procedures.
• Participate in third-party (Notified Body, FDA) audits as required.
• Escalate Quality issues to upper management based on risk and compliance.
• Provide coaching on auditing, root cause analysis and CAPA.

Skills

Problem solving

Root cause analysis

Risk management

Communication skills

Technical writing

Data-driven decisions

Certified auditor

Certified Quality Engineer

Quality system awareness

Education

Bachelor's degree in science (chemistry, microbiology or biotechnology)

Microbiology preferred

Tools

Veeva

SAP

Trackwise

Computer System Validation

Job description

Ferring Pharmaceuticals Inc. in Roseville, Minnesota, is seeking a Sr. Quality Engineer to provide QA support for biologics, ensuring compliance with cGMP and ICH/global regulations.

You will lead supplier quality, audits, CAPA, and quality system improvements across complex projects. The role calls for a Bachelor's degree in science with microbiology emphasis, 7+ years in GMP quality roles, and 3+ years in pharma.