Biological Dynamics, Inc. is a biotechnology company committed to improving global health outcomes by detecting disease in its earliest stages. Our proprietary Verita™ platform simplifies access to biomarkers, nanoparticles, and nucleic acids, enabling differentiated multiomics applications. We are applying our proprietary methods with machine learning to detect several diseases, including early-stage cancer, tuberculosis, and Alzheimer’s disease. For more information, please visit www.biologicaldynamics.com and follow us at @BiodynSD on Twitter.

Our talented staff thrives in an open working environment where curiosity, insights and vision are part of the equation. With an inclusive, family-friendly culture and comprehensive benefits package, we offer a terrific opportunity to discover, learn and grow. If you are ready to be inspired, challenged, and want to join a dynamic team where you can contribute to the next exciting breakthrough, we are the company for you.

Job Summary

The Quality Specialist is part of the Quality Department responsible for maintaining and strengthening Biological Dynamics’ quality system and EH&S program. The Quality Specialist is responsible for a variety of areas involved within Quality including document and change control, equipment calibration, monitoring and maintenance, and record keeping. This role is responsible for ensuring that all applications, systems, products, and processes meet defined quality standards. The Quality Specialist will assist with compliance to local, state, and federal EH&S regulation and standards. This position holds an active role with the Safety Committee.

Essential Job Duties

• Responsible for creating, editing, and maintaining procedural documentation including, but not limited to, department policies, procedures, and guidance documentation in the Company’s quality system.
• Ensures documents are in the appropriate quality system format.
• Organizes and maintains quality documents.
• Executes, schedules, and maintains routine equipment calibration.
• Monitors change activities approval/implementation and is able to resolve issues of various complexity.
• Assists in non-conforming and corrective and preventative action processes.
• Assists in developing quality systems and making recommendations for improvements to existing quality systems.
• Coordinates the collection and submission of data required to satisfy environmental permits and reporting requirements (eVQ questionnaire, Hazardous Materials Business Plan, and fire marshal inspection).
• Assists in a variety of Environmental Health and Safety (EH&S) efforts including programs to control, eliminate, and prevent occupational disease and/or injury caused by physical, chemical, biological agents, or ergonomic factors.
• Maintains safety records and other related documentation.
• Reviews local, state, federal EH&S regulations.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Develops solutions to a variety of problems.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Builds productive internal/external working relationships.

Education/Experience/Skills

• Typically requires a minimum of 2 years of related experience and Bachelor's degree, a Master's degree, or 4 years and a professional certification in a related discipline, or equivalent combination of education and experience.
• Ability to operate in a fast-paced environment, adapt to changes in priority, and redirect efforts as necessary.
• Experience with document and change management required.
• Familiar with laboratory equipment and tools required.
• Prior experience working in the laboratory preferred.
• Experience working with external vendors preferred.
• Working knowledge of EH&S and safety regulations a plus.
• Good organizational skills.
• Must be able to interpret Quality standards for implementation.
• Developing professional expertise, applies company policies and procedures to resolve a variety of issues. General application of concepts and principles.

The health and well-being of our employees is of utmost importance. Please be aware that, as a condition of employment, Biological Dynamics may require proof of COVID vaccination in accordance with local statutory requirements (subject to limited exceptions).