Senior Quality Engineer - Biopharma Compliance & Audits

ferring; Minneapolis (MN); In loco; USD 94.000 - 174.000; Tempo pieno

Descrizione del lavoro

Ferring is a privately owned biopharmaceutical company delivering life-changing therapies to help people build families and live healthier lives. The Sr.

Quality Engineer provides QA support under regulatory requirements for biologics, cGMP, and global standards, guiding supplier quality, validation, CAPA, audits, and quality system improvements. You will collaborate with internal teams and regulators, review investigations, participate in audits, and drive continuous process improvements.

Competenze

• Bachelor's degree in science (chemistry, microbiology or biotechnology) required.
• Minimum 7 years' GMP Quality experience.
• Minimum 3 years' experience in pharmaceutical industry.
• Demonstrated experience in problem solving, root cause analysis and risk management methods.
• High proficiency in Outlook, Word, PowerPoint, and Excel.
• Certified auditor/Quality Engineer preferred.
• Experience with computer system validation is a plus.

Mansioni

• Support supplier management including supplier qualification, audits, SCARs, and quality agreements.
• Manage suppliers of materials, parts, and services using a risk-based approach.
• Perform and support internal and external audits.
• Collaborate with internal teams and external regulators on compliance needs.
• Review and approve CAPA, audit findings, and deviation investigations.

Conoscenze

GMP quality experience

Problem solving

Data-driven decisions

Effective communication

Technical writing

Auditing

Formazione

Bachelor's degree in science (chemistry/ microbiology/ biotechnology)

Strumenti

Veeva

SAP

TrackWise

MS Office

Descrizione del lavoro

Ferring is a privately owned biopharmaceutical company delivering life-changing therapies to help people build families and live healthier lives. The Sr.

Quality Engineer provides QA support under regulatory requirements for biologics, cGMP, and global standards, guiding supplier quality, validation, CAPA, audits, and quality system improvements. You will collaborate with internal teams and regulators, review investigations, participate in audits, and drive continuous process improvements.