Quality Assurance and Safety Coordinator

JOB SUMMARY:

Position: Quality Assurance and Safety Coordinator

Company: Clin-Path Diagnostics, LLC

Reports to: Manager, Quality Operations

The Quality Assurance (QA) and Safety Coordinator plays an important role in supporting Clin-Path Diagnostics’ quality assurance, quality improvement, and safety programs. This position requires exceptional attention to detail, as well as a working knowledge of laboratory processes and procedures. The QA and Safety Coordinator is responsible for assisting with and supporting company projects and activities related to quality assurance, quality improvement, regulatory compliance, and laboratory safety.

The QA and Safety Coordinator assists with maintaining the company’s Quality Management Systems, monitoring quality and safety processes, coordinating continuing education and proficiency testing activities, supporting regulatory requirements, and assisting with CAP inspection preparation. This position requires knowledge of HIPAA rules and regulations and the ability to work independently with minimal supervision.

Employees are responsible for following all company policies and procedures, including adherence to CAP and other applicable state and regulatory requirements, as well as all established safety standards.

This position may support several areas and functions, including:

• Assisting with maintaining Quality Management Systems in compliance with regulatory and company requirements
• Compiling the monthly QA report
• Collecting and collating pathologist QA data and reports
• Coordinating continuing education and PIP programs for Pathologists and the laboratory
• Maintaining the daily QA system for Pathologist QA
• Performing weekly and monthly safety and waste inspections as required
• Assisting with quality monitoring and evaluation of laboratory processes
• Assisting with report design, graphical display, and analytical interpretation as needed
• Communicating and coordinating with laboratory leadership and other management teams regarding reports and quality-related activities
• Assisting with maintaining laboratory regulatory requirements
• Assisting with CAP inspection preparation
• Assisting with reviewing and updating policies and procedures related to quality assurance and safety
• Coordinating proficiency testing enrollment
• Ensuring timely distribution of proficiency testing reports and monitoring ongoing performance
• Assisting with the annual review of laboratory quality plans
• Supporting performance improvement and error reduction processes
• Performing administrative and clerical duties as needed
• Maintaining knowledge of HIPAA rules and regulations
• Working independently with minimal supervision and self-directing work as needed
• Performing other duties as assigned

Employees are responsible for following all company policies and procedures, including adherence to applicable regulatory and safety standards when performing all assigned duties.

ESSENTIAL FUNCTIONS:

Essential functions of the job include, but are not limited to:

Quality Assurance/Quality Improvement:

• Assists with maintaining Quality Management Systems to ensure compliance with regulatory and company requirements.
• Compiles the monthly QA report.
• Assists with collecting and collating pathologist QA data and reports.
• Maintains the daily QA system for Pathologist QA.
• Assists with quality monitoring and evaluation of laboratory processes.
• Assists with report design, graphical display, and analytical interpretation as needed.
• Assists with the annual review of laboratory quality plans and measures to maximize performance improvement and error reduction processes.
• Assists with reviewing and updating policies and procedures related to quality assurance and safety.

Regulatory/Safety:

• Performs weekly and monthly safety and waste inspections as required.
• Assists with maintaining laboratory regulatory requirements.
• Assists with CAP inspection preparation.
• Coordinates proficiency testing enrollment.
• Ensures timely distribution of proficiency testing reports and monitors ongoing performance.
• Maintains knowledge of HIPAA rules and regulations.
• Ensures compliance with applicable regulatory and safety requirements.

Administrative/Communication:

• Coordinates continuing education and PIP programs for Pathologists and the laboratory.
• Cooperates with laboratory leadership and other management teams to enable timely communication and review of reports.
• Performs administrative and clerical duties as needed.
• Works with minimal supervision and demonstrates the ability to self-direct.
• Performs other related duties as assigned.

PHYSICAL/MENTAL DEMANDS, ENVIRONMENT:

• Must be able to work effectively with Administrative and Professional staff.
• Must be able to work independently.
• Must be able to perform duties requiring manual dexterity for handling blocks and slides.
• Must be able to work in a laboratory setting.
• Must demonstrate exceptional attention to detail when performing quality assurance and safety-related duties.
• Must be able to effectively manage assigned responsibilities with minimal supervision.
• Must be able to follow established company policies, procedures, regulatory requirements, and safety standards.

EQUIPMENT USED:

• Computer equipment
• Phone and fax machines
• Software programs for virtual meetings, including Skype, Zoom, Teams, and similar programs
• Printer

SUPERVISORY RESPONSIBILITIES:

None.

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in a scientific or analytical-related field preferred.
• In lieu of a degree, a minimum of 2 years of experience in a QA or safety role is required.
• Experience with Microsoft Office Suite preferred.
• High proficiency in Microsoft Excel preferred.
• Working knowledge of laboratory processes and procedures.
• Knowledge of HIPAA rules and regulations.
• Ability to work independently and with minimal supervision.
• Ability to self-direct and effectively manage assigned responsibilities.
• Ability to work effectively with Administrative and Professional staff.
• Ability to follow company policies, procedures, regulatory requirements, and safety standards.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee may encounter while performing the duties of this job. The Quality Assurance and Safety Coordinator works in a laboratory setting and interacts with Administrative and Professional staff in support of quality assurance, quality improvement, regulatory compliance, and safety activities.

The position requires the ability to work independently, perform duties requiring manual dexterity for handling blocks and slides, and maintain a high level of attention to detail. Employees are expected to follow all applicable company policies, procedures, regulatory requirements, and safety standards.

Clin-Path provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability and gender identity.