Quality Systems Specialist I

ferring; Minneapolis (MN); On-site; USD 65,000 - 95,000; Full time

Job summary

Ferring US is seeking a Quality Systems Specialist I to support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) to ensure compliance with regulatory requirements and company procedures. The role provides operational support for deviations, CAPA, change control, document control, training, supplier quality, audits, and management reviews.

You will work under supervision while developing expertise in cGMP regulations and Quality Systems.

Qualifications

• Bachelor's degree in a scientific discipline or related field.
• 1-3 years of experience in a regulated pharmaceutical setting.
• Familiarity with deviations, CAPA, change control, document control, and training systems.

Responsibilities

• Support Quality System Processes and maintain compliance with regulatory requirements.
• Assist in implementing and improving QMS programs under supervision.
• Ensure quality records are complete and maintained per procedures.
• Coordinate deviation, nonconformance, CAPA, and quality event records in the QMS.
• Assist investigators with data gathering and documentation.
• Prepare audit materials and track audit findings and responses.
• Support training assignments and training record maintenance.
• Collaborate with Manufacturing, Quality Control, Regulatory Affairs, and other functions.

Skills

Quality Systems

cGMP knowledge

Documentation practices

Education

Bachelor's degree in a scientific discipline

Tools

eQMS

Job description

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.

As the Quality Systems Specialist I you will be responsible for supporting the implementation, maintenance, and continuous improvement of Quality Management System (QMS) processes to ensure compliance with applicable regulatory requirements and company procedures. This role provides operational support for Quality Systems activities including deviations, CAPA, change control, document control, training, supplier quality, audits, and management review processes. The Specialist I works under general supervision while developing technical expertise in cGMP regulations and Quality Systems requirements.

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.

Responsibilities:

• Support Quality System Processes
• Support the administration and maintenance of Quality Systems processes to ensure compliance with applicable regulatory requirements and internal procedures.
• Assist in the implementation and continuous improvement of Quality Management System (QMS) programs.
• Ensure quality records are complete, accurate, and maintained in accordance with applicable procedures.
• Investigation, Deviation, and CAPA Support
• Coordinate deviation, nonconformance, CAPA, and quality event records within the electronic Quality Management System.
• Assist investigation owners with gathering data, documenting facts, and maintaining investigation records.
• Track investigation and CAPA due dates and follow up with assigned action owners.
• Participate in root cause analysis activities under the guidance of senior Quality personnel.
• Escalate overdue or potentially high-risk issues to management.
• Audit Program Support
• Assist with the planning, scheduling, and coordination of internal and external audits.
• Prepare audit materials, maintain audit records, and track audit findings.
• Support the collection and verification of audit responses and evidence.
• Monitor audit commitments and assist with closure activities.
• Supplier Quality Support
• Support the Supplier Quality Engineer.
• Change Control, Document Control, and Training
• Process routine document revisions and support document control activities.
• Assist with periodic review activities and record retention processes.
• Support training assignments, training record maintenance, and training compliance monitoring.
• Review routine quality records for completeness and procedural compliance.
• Management Review and Metrics
• Compile Quality Systems metrics and prepare routine reports.
• Maintain tracking tools and dashboards used to monitor Quality System performance.
• Assist in data collection and preparation for Management Review meetings.
• Inspection Readiness Support
• Support regulatory inspection readiness activities
• Retrieve records and documentation requested during inspections and audits.
• Assist in maintaining inspection-related documentation and commitments.
• Continuous Improvement
• Participate in Quality Systems improvement initiatives and cross-functional projects.
• Identify opportunities to improve process efficiency and data quality.
• Support implementation of electronic Quality Management System (eQMS) enhancements.
• Other Responsibilities
• Collaborate effectively with Manufacturing, Quality Control, Technical Operations, Materials Management, Regulatory Affairs, and other functional groups.
• Perform additional duties as assigned to support business needs.

Requirements:

• Bachelor's degree in a scientific discipline or related field.
• 1-3 years of experience in the pharmaceutical, biotechnology, medical device, or other regulated industry.
• Co-op or entry-level Quality experience preferred.
• Basic understanding of cGMP regulations and Quality Systems concepts.
• Familiarity with deviations, CAPA, change control, document control, and training systems preferred.
• Strong organizational, communication, and time-management skills.
• Ability to manage multiple priorities and meet deadlines.
• Detail-oriented with strong documentation practices.
• Ability to work effectively in a cross-functional team environment.
• Demonstrates sound judgment and appropriately escalates