Senior Quality Engineer

ferring; Minneapolis (MN); Vor Ort; USD 94.000 - 174.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GMP quality experience

Problem solving

Data-driven decisions

Effective communication

Technical writing

Auditing

Ausbildung

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

Tools

Veeva

SAP

TrackWise

MS Office

Jobbeschreibung

Job Description:

As a privately- owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.

The Sr. Quality Engineer works under minimal supervision to provide quality assurance support in accordance with regulatory requirements as it relates to biologic therapeutics and compliance with cGMP, relevant ICH and Global regulations. This role will support the execution of medium complexity projects that will impact the Quality of the product significantly throughout the implementation of changes involving supplier related items, validation process, Quality Culture, risk management, process improvement, CAPA, internal audits and quality system improvements.

Responsibilities:

• Support supplier management process which may include supplier qualification, audits, SCARs, reviewing and providing input to Quality Technical Agreements and on-going supplier monitoring.
• Manage suppliers of materials, parts, and services through a risk- based approach.
• Perform and support internal and external audits.
• Interface and collaborate with internal departments and external regulatory bodies regarding compliance needs as required
• Support review and approve Complaint, CAPA, Audit Findings, Deviation investigations to provide guidance to ensure effective investigations are completed.
• Provide continued quality system support by improving processes and systems and by updating and creating site procedures.
• Participate in third party (Notified Body, FDA,) audits as required.
• Supports high-risk investigations to document Quality Issues resolutions within a CAPA, SCAR, Deviation, Audit finding to ensure proper and robust actions are taken to eliminate re-occurrence.
• May guide, coach, and train other personnel on topics such as auditing, Root Cause Analysis, CAPA, deviations, etc.
• Escalate Quality issues to upper management based on risk, trend, and compliance assessment.
• Ensure Site Metrics are complying with internal requirements and goals established.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Contributes to continuous process improvement efforts, improve efficiency, quality culture reinforcement, and eliminate waste.
• Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Performs other duties as assigned based on business needs.

Requirements:

• 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.
• High proficiency in use of standard electronic business tools: Outlook, Word, PowerPoint, and Excel.
• Effective communication skills of technical issues to various functional levels, ability to make data driven decisions, passionate for change and continuous improvement, and embodying a strong sense of urgency.
• Effective technical writing skills and ability to understand quality requirements as they relate to supplier negotiations and quality agreements.
• Certified auditor preferred.
• Certified Quality Engineer preferred.
• Experience in computer system validation requirements is a plus
• Experience in Veeva, SAP, and/or Trackwise is a plus

Ferring + you

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.

Our Compensation and Benefits

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $93,818 to $174,233