Job Description

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.

For more information, please visit .

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:

• Manage the document control program and proactively continue to improve the processes
• Responsible for assigning company-wide competency and continuing education training ensuring records are maintained and compliance to timelines are met
• Work with departmental leads to understand gaps and potentially improve training
• Support documentation of records for deviations, nonconforming material, CAPAs, etc.
• Support all QMS document owners/authors with document formatting and internal compliance standards
• Develop and provide training to entire organization on how to use the electronic document management system and the learning management system. Provide support training on the entirety of the electronic quality management system.
• Initiate and maintain training files monitoring for compliance and overseeing on-site and off-site storage and shipment
• Maintain the laboratory roles and responsibilities spreadsheet for real-time documentation of regulatory responsibilities
• Ensure proper and timely change control
• Manage metrics and trending for both document control and training
• Manage the monthly Laboratory Director test result review process
• Manage laboratory notebooks program and procedure
• Provide support for meeting facilitation for identified key meetings (tactical, Quality team, risk assessment, process improvements, others as identified)
• Provide support during external audits
• Assist with driving quality improvement initiatives inter-departmentally

REQUIREMENTS:

• Preferred minimum of 1 year in document control, training or quality in a regulated industry
• Knowledge and experience with QSR, ISO, CLIA, CLEP, CAP desired
• Strong experience and demonstrated proficiency with Microsoft Office
• Strong verbal, written, and interpersonal skills
• Must possess strong organizational and time management skills with the ability to prioritize and manage completion of multiple tasks/projects, communicating with team members and other department personnel when necessary
• Must be detailed oriented
• A motivated self-starter able to perform all the required skills of this position with minimal direction
• Ability to adapt to a startup and flexible with responsibilities

EDUCATION AND EXPERIENCE:

• Preferred Bachelor of Arts or Sciences or related experience in Quality or a regulated environment

COMPENSATION

• Hourly Base Salary Range $23 to $26
• Discretionary Bonus opportunity
• Comprehensive health coverage: Medical, Dental, and Vision
• Insurance: Short/Long Term Disability and Life Insurance
• Financial benefits: 401(k), Flex Spending Account
• 120 hours of annual vacation
• 72 hours of paid sick time off
• 11 paid holidays + 3 floating holidays
• Employee Assistance Program
• Voluntary Benefits
• Employee recognition program

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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