Senior Quality Engineer

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.

With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society’s unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.

• 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.

• 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…