Senior Quality Assurance Specialist

Company: Fulgent Genetics
Location: El Monte
Posted on: March 16, 2023

Job Description:

About Fulgent:

Fulgent is a leader in genetic and genomic clinical testing, a publicly traded company located in Los Angeles, California. We are a technology-driven company with extensive academic/clinical experience and capabilities in Next Generation Sequencing and bioinformatics. This distinction has advanced us to the forefront of the rapidly advancing genetic and genomic testing industry.

Fulgent's unique chemistries and superior proprietary bioinformatics pipeline has propelled our explosive growth in recent years. We offer the most expansive set of clinical genetic tests in the world, including 22,000+ single gene tests, 900+ preset panels, rearrangement testing, clinical exome/trios, whole exome/trios, whole genome and our All-in-One reflex test. We are a CLIA and CAP accredited laboratory. Fulgent has state-of-the-art clinical, sequencing and bioinformatics tools, including the latest Illumina sequencers such as the NovaSeq.

Summary of Position:

The Senior Quality Assurance Specialist position is responsible for managing, enforcing, coordinating and maintaining all functions associated with the company's Quality Management System. While focusing on the Quality Management System (QMS), the Quality Assurance Specialist will work closely with the Laboratory Medical Directors and Management to provide direction, oversight and input into the management and monitoring of the regulated areas. The Quality Assurance Specialist will be responsible for more than one site, but in addition will need to work with all other sites with regards to processes such as operating procedures, process improvement and occurrence management. The Quality Specialist assumes responsibility for maintaining a constant state of regulatory compliance.

Key Job Elements:

* Ensure and enforce compliance to the company QMS. Included will be the co-hosting and appropriate follow-up to site specific inspections by external regulating agencies (e.g. College of American Pathologists).
* Direct internal audit program for regulated areas as defined by the QMS. Document audit findings, report findings to the Medical Directors and inspect to verify completion of follow-up activities.
* Provide direction and management oversight for QMS activities including (but not limited to):
* Administer and monitor the Occurrence Management program.
* Enforce key performance indicators for quality as established by the Laboratory Medical Director.
* Ensure compliance of Proficiency Testing programs.
* Review & approve Standard Operating Procedures (SOPs) for compliance to the QMS.
* Assess proper level of training & competency for process changes.
* Manage elements of document control.

Qualifications

Knowledge & Experience:

* Bachelor's Degree in chemistry, biology, or related discipline.
* 5+ years' experience in a Clinical/Anatomic Pathology Laboratory setting preferred.
* 5+ years' Experience with Quality Management/Improvement, including performing audits and demonstrated record enforcing regulatory standards
* Certification as a Clinical/Medical Laboratory Scientist or sub specialty (e.g. ASCP certified Med Tech).
* Demonstrated leadership and management responsibilities within a regulated environment.
* Demonstrated skills in training, validation of clinical assays, written/oral communication, and computer skills are essential.
* Experience with document control software.
* Knowledge and ability to enforce CAP, CLIA, and state regulatory requirements such as New York State Department of Health
* Quality related certification(s) such as ASQ Quality Auditor, Quality Engineer, etc.
* Experience or certification with Lean/Six Sigma, TQM, SPC.

Environment:

Fulgent Therapeutics LLC is an Equal Employment Opportunity Employer.

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 qualified individuals with disabilities to perform the essential functions. The term "qualified individual with a disability" means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position.

Safety and Work Environment:

* General office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
* Maintains a clean, neat, and orderly work area.
* Adheres to Department Specific Safety Guidelines.

Physical Demands:

* Standing, sitting, walking, bending, reaching, manual manipulation, and lifting up to 10 pounds.
* Must pass a color vision test if responsibilities require color discrimination.

For California residents, please see the link below to access our CCPA Privacy Notice.

CCPA Privacy Notice for California Residents

https://tinyurl.com/FulgentCCPA

Keywords: Fulgent Genetics, El Monte , Senior Quality Assurance Specialist, Other , El Monte, California