Quality Specialist I

El Monte, CA, United States

Job Details

Level

Experienced

Job Location

Fulgent 4401 El Monte - El Monte, CA

Position Type

Full Time

Education Level

4 Year Degree

Salary Range

$70,000.00 - $75,000.00 Salary/year

Job Category

Biotech

Description

About Fulgent

Founded in 2011, Fulgent has evolved into a premier, full-service genomic testing company built around a foundational technology platform.

Through our diverse testing menu, Fulgent is focused on transforming patient care in oncology, anatomic pathology, infectious and rare diseases, and reproductive health. We believe that by providing a wide range of effective, flexible testing options in conjunction with best-in-class service and support, we can redefine the way medicine is managed for patients and clinicians alike.

Since integrating with our therapeutic development business, Fulgent is also developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform. By merging our fields of expertise, we aim to become a fully integrated precision medicine company.

Summary

The Quality Specialist I at Fulgent Genetics will be responsible for working with multiple departments across all functions and in the general execution and continuous improvement of Fulgent's Laboratory Quality Management System with emphasis in safety and quality compliance under CAP/CLIA, OSHA as well as other state and regulatory standards, process improvement implementation, inventory control and documentation maintenance. This role will contribute to promoting and maintaining a culture of quality and compliance throughout the organization.

Key Job Elements

Provide ongoing support in the compilation and organization of relevant data records for the quality system and regulatory compliance programs, including proficiency testing, assay or system validation and verifications, and more.

Participate in audit preparation, interim/self-inspections, as well as client/externally initiated audits.

Support Site EHS Activities such as Safety checks, Safety walk-thru and attend Safety Meetings.

Support investigations for quality failures and non-conforming practices by assisting with root causes and working with various departments to implement and fully document appropriate corrective actions preventive action plans (CAPA), with follow-up schedules to assess effectiveness of corrective and preventive actions.

Review, track and respond to supplier questionnaires.

Provide assistance to maintain and ensure continual compliance for staff training/personnel files, master schedule, incidents, and deviation trending/tracking documentation.

Ensure compliance of Proficiency Testing programs.

Assess proper level of qualification, training & competency for personnel and process changes.

Review, inspect and update controlled documents such as laboratory SOPs, regulatory, safety and environmental guidelines, in accordance to the most updated CAP/CLIA standards.

Organize records so that they are always up to date to enable the lab to always be inspection-ready.

Support employee onboarding/exit processes to maintain evacuation list updates, and ensure compliance with safety training, color blind assessment (as applicable) while promoting the quality culture within the company.

Other quality-related duties as assigned by the Quality Management manager.

Qualifications

Knowledge / Experience:

Minimum of a bachelor's degree in biology, chemistry, or other related sciences.

Experience in a CAP/CLIA-certified clinical laboratory setting with some involvement in regulatory or safety inspection preparedness preferred.

Experience and background in molecular biology and/or medical genetics field is a plus.

Strong working knowledge of state/local regulations, CAP/CLIA, IVDR, OHS/OSHA, FDA/ISO regulations, New York State clinical lab guidelines, and GLP/GDP standards.

Skills:

Detail-oriented and observant with exceptional verbal and writing ability.

Demonstrate proficiency in Microsoft Office or other similar applications for documentation and spreadsheet compilation.

Highly organized and able to demonstrate independence and a strong work ethic to execute multiple assignments with tight deadlines under minimal supervision.

Must have the aptitude to learn new processes and interpret and follow new rules and regulations.

Must have strong computer skills (typing and general navigation).

Ability to demonstrate and maintain professionalism in all regards.

Reports To:

Quality Management Manager

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 but includes routine presence at the lab and at other sites. Reasonable accommodations may be made to enable individuals with disabilities to perform the 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

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