Quality Systems Specialist
Quality Systems Specialist
Location: Remote
Overview
EPM Scientific is partnered with a commercial-stage specialty biopharmaceutical company to hire a Quality Assurance Specialist. This individual will play a key role in supporting and enhancing the company's Quality Management System (QMS) while helping ensure compliance across commercial manufacturing operations. Working within a lean and collaborative environment, the Quality Assurance Specialist will partner closely with internal stakeholders and external manufacturing partners to support quality systems, investigations, documentation, and continuous improvement initiatives. This is an excellent opportunity for someone looking to broaden their quality expertise and take on increasing responsibility within a growing organization.
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
- Coordinate and administer quality training programs to ensure compliance with internal and regulatory requirements
- Initiate 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
- Collaborate with cross-functional teams to support compliance and business objectives
- Assist 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
- Experience working within electronic Quality Management Systems (eQMS); ZenQMS experience preferred
- 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
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