ABOUT US
Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics.
Our Mission: Transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs.
Our Vision: A world where patient diseases are conquered with the guidance of personalized diagnostics.
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OVERVIEW:
The Document Control Specialist & Training Coordinator works cross-functionally to support QMS requirements to align and comply with regulations to ensure compliance to ISO, CLIA, NYS CLEP, CAP, etc. This position must promote and maintain quality policies, procedures, processes, programs, and practices associated with Document Control and Training to demonstrate conformance with appropriate standards and regulations.
The Document Control Specialist is responsible for quality assurance and compliance of the Document Control program, Training program, and management of laboratory notebooks throughout product lifecycle. This role is responsible for ensuring all documentation are structured and organized in accordance with the document control and training procedures. This is a dedicated, service-oriented resource to manage the process, improve system maintenance, develop meaningful, proactive metrics, and assist with functional groups to ensure the work is of quality standards but allows them to focus on their critical tasks. This is an opportunity to work for an exciting development and commercial diagnostics laboratory specializing in personalized medicine and have the opportunity for growth within a regulated industry.
RESPONSIBILITIES:
REQUIREMENTS:
EDUCATION AND EXPERIENCE:
COMPENSATION
Individual base compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects.
Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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