Job Summary:

We are seeking a highly skilled Director of Quality Assurance to oversee and manage our quality control processes. The ideal candidate will ensure that our products meet the highest industry standards and regulatory requirements.

Responsibilities:

• Updates the Quality Plan as necessary and informs management and affected staff of any changes.
• Works with laboratory leadership to update and conduct regular reviews of SOP’s and confirm they are appropriate for maintaining accreditation.
• In conjunction with laboratory leadership maintains awareness of all requirements issues by accrediting bodies including any changes or updates.
• Ensures all standards and requirements for accreditation are met including:

- Personnel competencies

- Laboratory instrumentation maintenance and services performed.

- Proficiency testing

- Documentation and follow-up are completed for any corrective action/preventive action incidents.

- Documentation is maintained for all new validations/ addendums.

• Administers MediaLab which includes:

- A bi-annual inspection to retire outdated SOP’s

- Personnel record retention

• Maintains record of all instrument data and laboratory personnel files.
• Lead internal audits and self-inspections.
• Track trends in Pre-analytical/ Analytical/ Post analytical aspects of the laboratory.
• Communicates all tests not performed and lab accidents to within 24 hours of discovery to comply with company TAT policies.
• Identifies and elevates quality incidents to lab management.
• Handles multiple tasks simultaneously and works in a fast-paced environment.
• Possesses strong independent problem-solving skills.
• Demonstrates willingness to accept additional responsibility with a positive attitude.
• Demonstrates ability to work independently and with a team.
• Demonstrates excellent attention to detail.
• Able to operate basic office equipment.
• Basic understanding of the functions of the clinical operations.
• Adheres to and assists in the laboratory implementation of all Quality Assurance policies and procedures. Will report to the Technical Supervisor, Laboratory Director, or Clinical Oversight Committee.
• Enters data into analysis templates with accuracy. Reports discrepancies to Manager according to pre-determined parameters.
• Directs and communicates with laboratory staff on QC failures, out of range values, quality trends etc.
• Gathers all analysis data for preparation of QA reports.
• Participates in the development, implementation, and maintenance of the company’s quality management system. Including SOP development and revision, document control, and corrective actions.
• Will be responsible for the generation and editing of incident reports for all departments. This will include root cause analysis investigations and long-term corrective action recommendations.
• Will need to ensure all quality assurance documentation is signed by appropriate personnel and filed for compliance reviews. Will be responsible for organizing follow up activities and document reviews as scheduled.
• Supports the laboratory in the preparation for, conduct of, and follow-up activities associated with site visits from regulatory/accrediting agencies. (CAP, CLIA..etc)
• Alerts management of quality problems and reports all problems to Technical Supervisor, Laboratory Director, or Clinical Oversight Committee.
• Provides support to process improvement activities for quality assurance functions such as quality, safety, document management and control, competency and training documents and proficiency testing.
• Gathers data and generates monthly metrics on pre-analytical, analytical, and post-analytical activities.
• Assists in internal audits and internal proficiency testing evaluations. Reports any quality issue findings and performs appropriate follow up activities thru resolution.
• Performs additional activities as assigned by Technical Supervisor, Laboratory Director, or Clinical Oversight Committee.

Skills:

• Bachelor’s Degree Required preferably in Biological Sciences
• Proficient in project management and quality control techniques
• Experience in conducting quality audits and implementing corrective actions
• Familiarity with CAP, CLIA regulations and quality systems
• Excellent leadership and communication skills
• Ability to analyze data and drive continuous improvement initiatives

If you are a dedicated professional with a passion for maintaining high-quality standards, we invite you to apply for this challenging and rewarding position as our Director of Quality Assurance.

Job Type: Full-time

Pay: From $75,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Required)

Work Location: In person