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)
|