Software Guidance & Assistance, Inc., (SGA), is searching for a Validation Engineer for a CONTRACT assignment with one of our premier Healthcare Services clients in A Remote Role.
Responsibilities :
Facilitate the definition of elements of F1LCDx that are FDA approved and a LDT and recommendation for where to capture these elements for compliance with requirements
Define the elements that need to be considered for LDT Validation
Work with the SAN team to build the lab validation and verification studies for San Diego
Build out the QMS structure for lab validation and verification
Draft updates and new procedures for lab validation and verification
Create validation templates which comply with laboratory requirements for use in SAN under the direction of the SAN project team and approval by Licensure and Accreditation
For those elements that are Laboratory Developed Tests, ensure that validations support compliance with laboratory regulations by defining the validation plans and scopes.
Support and guide the teams in writing the validation studies for San Diego.
Required Skills:
Specifically looking for a Clinical Laboratory Improvement Amendment (CLIA) expert in Next Generation Sequencing laboratory developed test validation per College of American Pathologist (CAP) Common, General, Atomic Pathology and Molecular checklist requirements.
5- 10 experience in clinical laboratory, pathology, academic research in molecular
5 years experince in labs or experience in LDT validation
PhD in Molecular Genetics, Clinical Chemistry, or Genomics
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com .
EEO Employer: Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status.
