Quality Systems Specialist - Remote

The Quality Systems Specialist plays a pivotal role in enhancing and maintaining The Jackson Laboratory’s electronic Quality Management System (eQMS). This role involves developing, implementing, and maintaining quality management system projects and support existing QMS operations. The Specialist ensures compliance with established standards, monitors and assesses global quality processes and drives continuous improvement to enhance customer satisfaction.

The salary range is $65,018 - $108,857. Salary will be determined based on qualifications and experience.

The candidate hired into this position will be able to work remotely and travel to JAX sites as needed (10%.)

Key Responsibilities (What you contribute) ​:

• Design, implement, and maintain improvements to quality management system in accordance with JAX standards and regulatory requirements.
• Support important Quality Management System processes, including by not limited to, Corrective and Preventive Action (CAPA), Deviations, Document Control, Change Management, Auditing and Supplier Management.
• Assist staff in effective management and adherence to compliance standards for various eQMS elements.
• Contribute to the enhancement of the overall eQMS, responsibilities including maintenance and administration of eQMS components, creation, review, verification, and approval of system documentation.
• Generate and analyze metrics about assigned Quality Management element(s) for leadership.
• Identify areas for improvement within the QMS and implement changes to enhance efficiency and effectiveness.
• Assume other projects and duties as required, demonstrating flexibility and adaptability.
• Assist in the development and implementation of eQMS-related training programs and materials.

Minimum Qualifications:

• Bachelor’s degree in a related field.
• Quality Management System: 3-5 years of experience in quality management systems or related roles.
• Strong knowledge and experience with ISO 9,001 standards.
• Strong experience running CAPA's and deviations.
• Certification in quality management (e.g., Lean Six Sigma, ASQ) is a plus.
• EtQ Reliance Certification is preferred.
• Documentation Standards: Understanding of proper documentation practices and record-keeping.
• Project Management: ability to organize, manage and monitor multiple projects to successful completion, adapting to shifting priorities.
• Highly organized, process driven with precise attention to detail.
• Excellent analytical and problem-solving skills.
• Skilled at engaging stakeholders effectively at all organizational levels.
• Demonstrated team player with a professional approach to collaboration.
• Communicates and collaborates effectively with colleagues.
• Experience with the following systems strongly desired: SharePoint, Workday, Microsoft Office, InfoEd, EtQ Reliance.
• Experience with word-processing, spreadsheets, data analysis, statistical analysis and other computer software to record, analysis and report activities.

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About JAX:

The Jackson Laboratory is an independent, nonprofit biomedical research institution with a National Cancer Institute-designated Cancer Center and nearly 3,000 employees in locations across the United States (Maine, Connecticut, California), Japan and China. Its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health.

Founded in 1929, JAX applies over nine decades of expertise in genetics to increase understanding of human disease, advancing treatments and cures for cancer, neurological and immune disorders, diabetes, aging and heart disease. It models and interprets genomic complexity, integrates basic research with clinical application, educates current and future scientists, and provides critical data, tools and services to the global biomedical community. For more information, please visit www.jax.org​​​​​​​.

EEO Statement:

The Jackson Laboratory provides equal employment opportunities to all employees and applicants for employment in all job classifications without regard to race, color, religion, age, mental disability, physical disability, medical condition, gender, sexual orientation, genetic information, ancestry, marital status, national origin, veteran status, and other classifications protected by applicable state and local non-discrimination laws.