Quality Manager Laboratory Services Full Time

MAJOR RESPONSIBILITIES/ESSENTIAL FUNCTIONS

The primary job duties this position is responsible for achieving are listed in order of importance.

Position Summary:

The Quality Manager is responsible for maintaining, updating and improving the Quality Management System, including policies, processes and procedures, and for performing/overseeing associated Quality functions, to ensure compliance with applicable regulatory and company standards.

Duties:

Compliance/Safety Officer

Responsibilities:

• Compiles safety programs and promotes safety initiatives.
• Practices safe working techniques.
• Implements and maintains laboratory safety standards.
• Maintains compliance with all safety regulations.
• Standardizes safety in order to remain consistent.
• Conducts regular safety meetings to share best practice techniques.
• Identifies hazardous waste and proper disposal.
• Regular inspection of the Laboratory for safety issues.
• Leads/hosts in required orientation, Safety and HIPAA training programs.
• Reports concerns and suspected incidences of safety issues to laboratory management.
• Partners across the Clinical Laboratory and Management team members to promote a quality driven mindset aligned with the company's vision and goals.
• Responsible for all QA and document control processes, including administration and management of internal audits, record maintenance and archiving.
• Maintains, monitors and improves the effectiveness of the QMS.
• Establishes, implements, monitors performance of, and reports on company Quality Metrics.
• Leads all quality-related inspections/inquiries and investigations for client, regulatory and internal audits.
• Assists in interactions with and submissions to CLIA/State, Regulatory and Accreditation agencies as required.
• Ensures laboratory licensures are in good standing and qualified licensed personnel are performing testing.
• Ensures quality documentation and records (SOPs, validations, event logs, non-conformances, audit findings) are reviewed and approved in a timely manner.
• Manages training materials, competency records and quality training matrix.
• Ensures that the corrective action plans are in place and followed upon inspection of work.
• Applies systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
• Monitoring performance by gathering relevant data and producing statistical reports.
• Project and goal management.
• Demonstrates leadership through influence, coordination and cooperation.
• Special projects as assigned by Management.

JOB QUALIFICATIONS

Minimum Education (Indicate minimum education or degree required.)

Bachelor of Science in Chemistry, Biology, Clinical Laboratory Science

Preferred Education (Indicate preferred education or degree required.)

Minimum Work Experience and Qualifications (Indicate minimum years of job experience, skills or abilities required for the job.)

• 5+ Laboratory experience
• Strong verbal and written communication skills
• Demonstrates critical analysis and complex problem-solving skills
• Demonstrates ability to manage quality and processes highly confidential and proprietary information
• Proficient in computer skills that include spreadsheets, word processing software and Microsoft Office required
• Knowledge of accreditation regulations
• Knowledge of CLIA and State laws regarding laboratory operations and billing
• Knowledge of OSHA laws and regulations

Preferred Work Experience and Qualifications (Indicate preferred years of job experience, skills or abilities required for the job.)

5+ years of experience on Quality Management preferred

Required Licensure, Certification, Registration or Designation (List any licensure or certification required and specify name of agency.)

• CLS License (CDPH/ASCP)
• Current Los Angeles County Fire Card required (within 30 days of hire)
• Assault Response Competency (ARC) required (within 30 days of hire)

Status: Full Time Exempt

Shift: Days

Hours: 8hrs (Exempt)

Weekly/Bi-Weekly Hours: 40hrs/80hrs (Exempt)

FTE: 1.0