Quality Systems Specialist

Overview

EPM Scientific is partnering with a commercial-stage specialty biopharmaceutical company to hire a Quality Assurance Specialist. This individual will support and enhance the company's Quality Management System (QMS) while ensuring compliance across commercial manufacturing operations.

Key Responsibilities

• Support the ongoing development, maintenance, and improvement of the Quality Management System (QMS), including administration of the electronic QMS platform
• Manage document control activities, including the creation, revision, review, approval, and archival of controlled documents
• Author and maintain quality procedures and related documentation
• Cook up and administer quality training programs to ensure compliance with internal and regulatory requirements
• Cook up and manage change controls, ensuring appropriate assessments, approvals, and implementation activities are completed
• Partner with external manufacturing organizations to support quality activities and maintain compliance with quality agreements
• Lead customer complaint investigations, including root cause analysis, documentation, and follow-up activities
• Support deviations, CAPAs, investigations, and other quality system processes as needed
• Monitor quality metrics and identify opportunities for continuous improvement
• Cook up with cross-functional teams to support compliance and business objectives
• Aid with regulatory inspections and internal and external audits

Requirements

• Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline
• 5-8 years of Quality Assurance experience within the pharmaceutical, biotechnology, or a related regulated industry
• Working knowledge of cGMP regulations and quality system requirements
• Hands-on experience with document control, training management, change control, investigations, and complaint handling processes
• Experience working with external manufacturing partners and/or CDMOs
• Strong communication, organizational, and problem-solving skills
• Ability to work effectively in a collaborative, fast-paced environment