Director of Clinical Laboratory Operations - Orange, United States - The Edge Treatment Center

The Edge Treatment Center Orange, United States

1 week ago

Description

Director of Clinical Laboratory Operations for EZ Checkup

Role Description:

We are seeking a Director of Clinical Laboratory Operations to help us build a brand new toxicology lab in Orange County with a primary focus on supporting patients in treatment for substance use disorders.

This is a fantastic opportunity for someone who would like to oversee the development, opening, and growth of a clinical lab throughout the entire process.

You'll help us build policies and procedures, set protocols, build a culture of compliance and excellence, train staff, and grow the lab.

You'll work with our outside consultant through this process, as well as with our expansion team throughout the opening of the lab.

We will start with an initial application for moderate complexity testing in two sub-specialties: chemistry and toxicology (screening only), but expand into a high complexity lab over time.

You'll also be responsible for ensuring that the Laboratory is compliant and for verification and validation of all assays.

The ideal candidate possesses at least a doctoral degree in chemistry, toxicology, or clinical laboratory sciences with NRCC Board Certification and a CDPH Clinical Laboratory Bioanalyst license (CLB).

Candidate must be in good standing to validate and oversee high-complexity confirmatory toxicology testing.

This position proves a unique opportunity to create a laboratory space with a team that values high quality patient care and making a difference in people's lives.

The laboratory space is modern with several amenities that make for a fun working environment.

EZCheckup is proudly an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.

Job Type:
Full-time Schedule: Monday - Friday; hours somewhat negotiable

Salary Range:
$85,000 - $130,000

Work Location:
One Location

Laboratory Type:
Independent reference laboratory

Specialties:
Clinical Chemistry, Toxicology

Physical Requirements:
Lift up to 25 lbs

Responsibilities:

Work with our Expansion team through the process of preparing and applying for CLIA certification through CMS or applicable CMS-approved agency
Ensure the laboratory meets all Federal, State, and Local regulatory and accreditation requirements (CMS/CLIA, OSHA, Hazardous Waste)
Proactively identify, and independently solve, laboratory operational needs
Train clinical laboratory scientist(s) to perform the day to day operations of the laboratory
Serve as subject matter expert for CLIA documentation during audits; ensure documentation, trainings, and procedures are prepared for a clinical diagnostic lab audit
Serve as EH&S officer for the laboratory; responsible for identifying and correcting any areas of non-compliance and developing systems and plans to ensure continual compliance
Create and maintain systems to ensure optimal quality, safety and efficiency of laboratory services (Quality Systems, Personnel Training & Competency, Proficiency Testing, Documentation Systems, Occurrence Management)
Partner with leadership on the timing of CLIA certification to ensure alignment with company goals

Requirements (Moderate-Complexity):

4 year degree or equivalent experience in the field of chemistry, biology, laboratory science, or a related field
3+ years of experience as a supervisor, manager, or administrative director of a CLIA-certified high-complexity clinical laboratory
Must possess a valid CDPH Clinical Laboratory Bioanalyst license (CLB)
Experience in toxicology/chemistry

Preference will be given to candidates who are qualified to oversee High-Complexity testing:

Licensed MD/DO/DPM AND certified in anatomic or clinical pathology OR 1 year of lab training during medical residency OR 2 years experience directing or supervising high complexity testing. OR
Doctoral degree in laboratory science AND certified by an HHS-approved board OR prior to 02/24/2003, served as Lab Director AND 2 years lab training or experience AND 2 years experience supervising or directing high complexity testing. OR
Qualified as Lab Director under state law or Medicare lab regulations prior to 02/28/1992.
3+ years experience with immunoassay and mass spectrometry

Additional Traits:

Expert knowledge of laboratory workflows and QC and QA
Excels working in an unstructured, autonomous environment
Demonstrated experience identifying projects, taking ownership, and executing quickly with high attention to detail and limited direct oversight
Able to integrate information from multiple sources, make decisions with documented rationale, and execute efficiently
Communicates well with upper management and outside consultant to deliver updates in a timely manner, provide feedback, and work collaboratively to meet team goals
Excited by challenges and eager to invent and deploy creative solutions
Driven by desire to provide high performing, quality lab services
Experience overseeing implementation or upgrades to Laboratory Information (Management) Systems is a plus

Notes:
We appreciate that your background and experience may not match the description exactly, but if you think you would be a good fit for this position, we invite you to apply and would be happy to discuss

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