Laboratory Compliance Officer Job at Gnosis Dx, Irvine, CA

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  • Gnosis Dx
  • Irvine, CA

Job Description

Job Description

Summary:

We are seeking an experienced Laboratory Compliance Officer to help drive a culture of quality, safety, and regulatory excellence across our laboratories. In this role, you will partner with the Director of Compliance to implement and maintain SOPs, monitor adherence to policies and regulations, and provide hands-on guidance to managers and staff. Your work will be essential in ensuring our laboratory operations maintain the highest standards of integrity, accuracy, and compliance.

Who are we:

We believe in connection at Gnosis — knowing we’re the link to the future standard of clinical diagnostic testing and screening excellence. We’ve pioneered what it means to bring the most advanced, revolutionary technology directly to those we serve. Our proprietary technology platform provides easy, intuitive access to the kind of information that helps you to make life changing decisions about your health. We will never stop pushing the boundaries of possibility, always driving to bring you better, faster, more reliable results than ever before.

Benefits: We put our employees' health first by covering 100% of their medical, dental, and vision insurance premiums.

Travel: This is on-site position based in Irvine. The role requires travel to company sites in Orange, Hemet, and other locations throughout Orange County. Mileage reimbursement is provided.

What you will do:

  • 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

Educational Requirements:

  • High School Diploma (or equivalent)
  • Bachelor's degree in biology or closely related scientific field (preferred)
  • At least 2 years of laboratory experience is required

Other Qualifications:

  • 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

We believe in the power of diversity and the strength it brings to our team. We are proud to be an Equal Employment Opportunity employer, committed to creating an inclusive environment where all individuals are welcomed, valued, and respected. We do not discriminate in hiring based on sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, veteran status, or any other characteristic protected by federal, state, or local law.

Job Tags

Local area, Immediate start,

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