Quality Assurance and Safety Coordinator

clinpathdiagnostics

Phoenix (AZ)

Hybrid

USD 60,000 - 75,000

Full time

3 days ago

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Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

401(k) retirement contributions

Flexible spending account (FSA)

Job summary

Clin-Path Diagnostics, LLC is seeking a Quality Assurance and Safety Coordinator to support QA, safety programs, and regulatory compliance within a clinical laboratory setting. The role emphasizes attention to detail and independent work with CAP and HIPAA standards.

This position may involve maintaining Quality Management Systems, coordinating education and proficiency testing, and assisting with CAP inspections. Hybrid work arrangement is available for this role.

Qualifications

Bachelor’s degree or 2+ years QA/safety experience in a laboratory setting.
Knowledge of HIPAA rules and regulations is required.
Strong attention to detail and independent work style.
Experience with Quality Management Systems and CAP/regulatory requirements is preferred.
Proficiency in Microsoft Office, especially Excel, is desirable.
Ability to communicate effectively with laboratory staff and leadership.

Responsibilities

Maintain Quality Management Systems and regulatory compliance.
Compile monthly QA reports and collate pathologist QA data.
Coordinate continuing education and proficiency testing programs.
Perform weekly and monthly safety and waste inspections.
Support CAP inspection preparation and policy reviews.
Communicate findings with laboratory leadership and management.

Skills

Quality Assurance

Regulatory compliance

HIPAA knowledge

Laboratory processes

Attention to detail

Education

Bachelor’s degree in a scientific or analytical-related field

2+ years QA/safety experience (in lieu of degree)

Job description

JOB SUMMARY:

Position: Quality Assurance and Safety Coordinator
Company: Clin-Path Diagnostics, LLC
Reports to: Manager, Quality Operations
Hours/Schedule: Monday - Friday 10:00 AM - 6:30 PM (Hybrid Schedule)

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 and employee encounters while performing the duties of this job. 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. Clin-Path complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This applies to all terms and conditions of employment including, recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation, and training.

BENEFITS:

Clin-Path Associates offers nationally competitive compensation and benefits. Our benefits program provides a comprehensive array of services to our full-time employees, including but not limited to: