Gnosis Dx · 1 week ago
Laboratory Compliance Officer
Irvine, CA
Full-time
Onsite
Entry, Mid Level
$33/hr - $36/hr
2+ years expGnosis Dx is a company focused on clinical diagnostic testing and revolutionary technology. They are seeking an experienced Laboratory Compliance Officer to drive a culture of quality, safety, and regulatory excellence across their laboratories, ensuring compliance with relevant regulations and standards.
Alternative MedicineBiotechnologyClinical TrialsHealth CareHealth DiagnosticsMedicalMedical DevicePharmaceutical
Hiring Manager
Nicole F.
Responsibilities
Advise appropriate staff, and ensure compliance with CAP/CLIA, OSHA regulations regarding laboratory safety
Monitor all quality assessment activities accomplished by each department
Prepare and ensures that all monthly key indicator matrix is reviewed by the Director of Compliance and Laboratory Director
Coordinate all QA meetings as scheduled and as necessary
Ensures that issues are investigated and any corrective and/or preventive actions are completed and documented on a timely manner
Enforce compliance with federal, state and local safety laws, regulations, codes and rules
Manage and update Safety Data Sheets (SDS) for all labs and ensure all SDS binders are complete and up to date
Have knowledge of emergency response procedures for fires, spills, exposures, and forces of nature
Conduct inspections and audits to assess employee compliance regulations are up to date and current
Conduct emergency response drills (i.e. fire, etc.) and maintain records
Maintain records regarding safety training, area specific training procedures and safety equipment like showers, eye washes, first aid, fire extinguishers, etc. in each area and ensures every lab member learns where these are located
Monitor the use and disposal of chemicals and biohazardous materials from all lab areas per state and federal guidelines and coordinate with external vendors for hazardous waste disposal (as applicable)
Stops operations and activities that could harm employees or equipment and immediately reports incident to the Director of Compliance, or COO
Other duties as needed to support the department
Qualification
Required
High School Diploma (or equivalent)
At least 2 years of laboratory experience is required
Good understanding of occupational safety and health standards
Strong working knowledge of laboratory regulations (e.g., CLIA, CAP, CMS, OSHA, HIPAA, state laboratory laws)
Experience with audits, inspections, and regulatory readiness
Unwavering integrity and the ability to promote the importance of complying with rules and regulations
Excellent organizational skills and attention to detail
Preferred
Bachelor's degree in biology or closely related scientific field
Benefits
We put our employees' health first by covering 100% of their medical, dental, and vision insurance premiums.
Mileage reimbursement is provided.
Company
Gnosis Dx
We believe in connection at Gnosis - knowing we are the link to the future standard of clinical diagnostic testing and screening excellence.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase