Job description
GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com.
Summary
The position will serve an integral role supporting the Associate Lab Director. provides support to the CLIA Laboratory Director on day-to-day basis on reviewing validations, SOPs and other documents, manages proficiency testing program, license changes/renewals, keeping up to date on regulatory changes and providing updates to CLIA LD as needed and working closely with Quality Systems team on audits/inspections.
Job Responsibilities
- Assist ALD in preparing validation documents for review e.g., formatting Microsoft Word, Excel documents
- Assist in preparing forms/documents for license renewals
- Learn NYS test submissions process to support Lab Director team in these efforts
- Learn and understand CAP/CLIA/NYS checklists and standards to support Lab Director team
- Learn FDA LDT regulations to support Lab Director team
- Assist in collection of proficiency testing attestations from the different groups
- Work cross-functionally among teams to assist ALD in day-to-day activities
- Maintain and supplement organization of regulatory records.
- Experience in Next Generation Sequencing and other molecular techniques is required
- Experience with Microsoft Office applications is a must
- Performs other related duties as assigned
Education, Experience, and Skills
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- BA or BS degree
- Excellent oral and written communication skills
- Excellent organizational skills and ability to multitask
- Computer skills at office professional level required
- Some familiarity required with: NYS Clinical Lab Evaluation Program, and/or CAP regulations on clinical test validation; and/or genetic testing methods
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
#LI-REMOTE
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Science - Minded, Patient - Focused.
At GeneDx, we create, follow, and are informed by cutting-edge science. With over 20 years of expertise in diagnosing rare disorders and diseases, and pioneering work in the identification of new disease-causing genes, our commitment to genetic disease detection, discovery, and diagnosis is based on sound science and is focused on enhancing patient care.
Experts in what matters most.
With hundreds of genetic counselors, MD/PhD scientists, and clinical and molecular genomics specialists on staff, we are the industry’s genetic testing experts and proud of it. We share the same goal as healthcare providers, patients, and families: to provide clear, accurate, and meaningful answers we all can trust.
SEQUENCING HAS THE POWER TO SOLVE DIAGNOSTIC CHALLENGES.
From sequencing to reporting and beyond, our technical and clinical experts are providing guidance every step of the way:
TECHNICAL EXPERTISE
- High-quality testing: Our laboratory is CLIA certified and CAP accredited and most of our tests are also New York State approved.
- Advanced detection: By interrogating genes for complex variants, we can identify the underlying causes of conditions that may otherwise be missed.
CLINICAL EXPERTISE
- Thorough analysis: We classify variants according to our custom adaptation of the most recent guidelines. We then leverage our rich internal database for additional interpretation evidence.
- Customized care: Our experts review all test results and write reports in a clear, concise, and personalized way. We also include information for research studies in specific clinical situations.
- Impactful discovery: Our researchers continue working to find answers even after testing is complete. Through both internal research efforts and global collaborations, we have identified and published hundreds of new disease-gene relationships and developed novel tools for genomic data analysis. These efforts ultimately deliver more diagnostic findings to individuals.
Learn more About Us here.
Our Culture
At GeneDx, we are dedicated to cultivating an environment where creativity and innovation thrive. We believe in the power of community and collaboration, where diverse perspectives are embraced, and every voice contributes to our shared success. Our team is a vibrant mix of professionals who challenge and support each other in equal measure, fostering growth both personally and professionally. When you join us, you're not just taking on a job—you're joining a movement. A movement that champions curiosity, embraces change, and believes in making an impact, one patient at a time. Cultural principles we live by:
- Be bold in our vision & brave in our execution.
- Communicate directly, with empathy.
- Do what we say we're going to do.
- Be adaptable to change.
- Operate with a bias for action.
Benefits include:
- Paid Time Off (PTO)
- Health, Dental, Vision and Life insurance
- 401k Retirement Savings Plan
- Employee Discounts
- Voluntary benefits
GeneDx is an Equal Opportunity Employer.
All privacy policy information can be found here.
Required profile
Experience
Other Skills
- Microsoft Office
- Quality Control
- Multitasking
- Organizational Skills
- Computer Literacy
- Communication
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