OBJECTIVE OF THE POSITION:

The Document Control Specialist 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. 

 

POSITION SUMMARY:

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, DHFs and records 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. 

 

This role shall comply, at a minimum, with the responsibilities outlined in:


  • CLIA: Clinical Laboratory Improvement Amendments (CLIA) Requirements, Title 42 Code of Federal Regulations Part 493
  • CAP: College of American Pathologists (CAP): All Common, General, Chemistry, Director Responsibility and Authority and Molecular Pathology checklists
  • NYS CLEP: New York State Department of Health, Clinical Laboratory Evaluation Program (CLEP), New York State Public Health Law, Article 5 Title 5
  • ISO: International Organization for Standardization (ISO) 13485, Quality Management Systems, Requirements for Regulatory Purposes, 2016
  • All other applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, MD)  


ESSENTIAL FUNCTIONS:


  • Manage the electronic and paper-based 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 originators with document formatting and internal compliance standards.
  • Develop and provide training to entire organization on how to use the electronic document control system Veeva and the learning management system, Docebo.
  • Initiate and maintain training files and binders 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.
  • Other duties as assigned.

 

COMPETENCY OR POSITION 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:

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

 

PHYSICAL FACTORS:


The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to stand, move through building and sit for extended periods of time.  Employee must be able to pick up 20lbs.

 

WORKING CONDITIONS:


Standard business shifts, overtime requirements as needed.


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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