Quality Systems Specialist I - CAPA & Audit Support

Ferring Pharmaceuticals Inc.; Minneapolis (MN); On-site; USD 63,000 - 117,000; Full time

Benefits offered by this job

Paid parental leave

401k with company match

Wellness benefits

Job summary

Ferring Pharmaceuticals Inc. in Minnesota is seeking a Quality Systems Specialist I to support QMS processes, deviations, CAPA, change control, document control, training, supplier quality, audits, and management reviews. You will help ensure cGMP compliance and quality system effectiveness under supervision.

Join a company recognized for innovation and a people-first culture. This role offers opportunities to grow technical expertise in quality systems while collaborating across functions to

Qualifications

• Bachelor's degree in a scientific discipline or related field.
• 1-3 years of experience in pharmaceutical/regulated industry; co-op or entry-level possible.
• Basic understanding of cGMP regulations and Quality Systems concepts.
• Familiarity with deviations, CAPA, change control, document control, and training systems preferred.

Responsibilities

• Support the administration and maintenance of Quality Systems processes to ensure compliance with 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 per procedures.
• Coordinate deviation, nonconformance, CAPA, and quality event records within the electronic QMS.
• Assist investigation owners with data gathering and documentation.
• Track investigation and CAPA due dates and escalate overdue issues.
• Assist with internal and external audits planning, scheduling, and coordination.
• Support training assignments, training records, and training compliance monitoring.
• Collaborate with Manufacturing, QC, Regulatory, and other groups.

Skills

Quality systems

cGMP familiarity

Documentation practices

Cross-functional teamwork

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Office

eQMS

Job description

Ferring Pharmaceuticals Inc. in Minnesota is seeking a Quality Systems Specialist I to support QMS processes, deviations, CAPA, change control, document control, training, supplier quality, audits, and management reviews. You will help ensure cGMP compliance and quality system effectiveness under supervision.

Join a company recognized for innovation and a people-first culture. This role offers opportunities to grow technical expertise in quality systems while collaborating across functions to