What are the responsibilities and job description for the CLIA Laboratory Supervisor position at Cleveland Diagnostics Inc.?
Our team is growing, and we currently have an immediate opening for a CLIA Laboratory Supervisor
Title
CLIA Laboratory Supervisor
Location
Onsite-Cleveland Office
Reports To
Director of Laboratory Services
Job Overview
The CLIA Laboratory Supervisor supervises all operations of the CAP-accredited CLIA laboratory at Cleveland Diagnostics. They will manage laboratory personnel and ensure that patient samples are processed accurately in a timely manner according to regulatory standards and internal SOPs. The CLIA Laboratory Supervisor will support departmental initiatives and work alongside the Director of Clinical Laboratory Services to ensure the lab maintains accreditation and is adequately prepared for changes in sample volume.
Essential Duties & Responsibilities
- Supervises and supports CLIA Laboratory team
- Ensures patient samples are processed accurately in a timely manner within advertised TAT
- Proactively plans for changes in sample volume
- Plans, organizes and directs staffing including activities related to hiring, scheduling, evaluating, and continuing education
- Point-person for issue resolution related to accessioning or sample processing
- Ensures adherence to standards from CLIA, CAP, NYS, and other agencies and states
- Performs moderate and high complexity analytical processes without direct supervision. Includes operation of immunoassay analyzers, clinical chemistry analyzers, and standard wet chemistry equipment such as pH meters, spectrophotometers, automated liquid handlers, etc.
- Develops and updates to current standard complete technical procedure manuals per CAP, CLIA, and NYS Guidelines
- Develops and implements contingency plans to avert possible interruptions in services due to technical or mechanical issues
- Works with Quality team to complete competencies of all technical staff utilizing the CLIA-defined competency elements
- Communicates downtime exceptions (instrumentation) to appropriate staff within a timely manner
- Demonstrates competency in statistical analysis, quality control review and instrument linearity/correlations
- Promotes participation among technical and support staff in Performance Improvement activities. Empowers Laboratory staff to assist with problem resolution.
- Adheres to the company’s quality control policies; documents all quality control activities including calibrations and maintenance performed. May develop and implement additional quality control policies and documents to support product development.
- Maintains instruments and equipment in accordance with the manufacturer’s specifications
- Maintains clear and legible records
- Plans, organizes, performs, and monitors daily project activities
- Responsible for materials management including effective utilization of supplies and monitoring of inventory to maintain suitable stock
- Other duties as assigned
Qualifications
- BA/BS in Chemical, biological or clinical laboratory science
- MT (ASCP) or MLS (ASCP) certification preferred
- Four years of experience working in a High Complexity clinical or CLIA lab environment with at least two years of supervisory experience
- Experience operating and maintaining Roche Cobas e411 and/or 6000 clinical chemistry and immunoassay analyzers preferred
- Experience working with and/or developing ELISA assay preferred
- Understands and complies with good laboratory practices, including safety, HIPPA, confidentiality, and regulatory requirements
- Requires critical thinking skills and decisive judgment skills
- Must be a self-starter with high motivation level and eagerness to learn
- Detail oriented
- Excellent aptitude for troubleshooting laboratory equipment
- Effective interpersonal, organizational, and communication skills required
- Excellent computer skills with proven proficiency in Microsoft Office products including Word and Excel
Physical Requirements/Working Conditions/Equipment used:
- Fine motor skills and manual dexterity to handle specimens and lab equipment required to process specimens, troubleshoot and repair instrumentation
- Visual acuity to examine specimens and reagents
- Offices reachable by elevator but should be able to climb stairs if needed
- Light lifting may be required (up to 25 pounds)
- May be required to stand for long periods of time
- Ability to operate a computer and other technology related lab equipment through course of day
- Ability to work in an environment with exposure to hazardous chemicals and biohazards
- Ability to comply with all appropriate job PPE requirements
- General office and HVAC noise
Other Requirements
- COVID-19 vaccination is recommended
- Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples).
- Full-time on-site position. This is not a remote position.
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Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee’s well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.
Cleveland Diagnostics offers an extremely robust benefits package which includes:
- 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
- 100% Employer-paid Dental & Vision for entire family
- No cost for employee coverage for Group Term Life, Short & Long Term Disability
- 4% retirement contribution Employer match
- Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
- Paid Family Leave Program
- Generous PTO plan & holiday program
- Flexible work schedule & lucrative employee referral program
- Salary range may vary by work state/geographical region/territory
- Easy to get to office location with newly built-out office space
- Free coffee, snacks and other goodies all day long
Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company’s status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.
