This role is responsible for ensuring compliance with Bioanalytical Lab QA (GLP/FDA) as well as CLIA/CAP requirements and partnering closely with scientific and laboratory teams to maintain a robust quality system supporting biomarker, IHC, and bioanalytical assay activities
Job Summary
This role is responsible for ensuring compliance with Bioanalytical Lab QA (GLP/FDA) as well as CLIA/CAP requirements and partnering closely with scientific and laboratory teams to maintain a robust quality system supporting biomarker, IHC, and bioanalytical assay activities.
Key Responsibilities include maintaining and improving the Quality Management System (QMS), developing SOPs, leading FDA inspection readiness and audits, and managing CAPA, deviations, change control, and document control systems.
SystImmune offers a comprehensive benefits package including 100% paid employee premiums for medical/dental/vision, STD, LTD, a 401(k) plan with a 50% company match, and 15 PTO days per year.
Matching Summary
This role is responsible for ensuring compliance with Bioanalytical Lab QA (GLP/FDA) as well as CLIA/CAP requirements and partnering closely with scientific and laboratory teams to maintain a robust quality system supporting biomarker, IHC, and bioanalytical assay activities.
Salary
Base: $120,000 - $160,000 annually; Bonus/Equity: Not specified; Benefits: 100% paid employee premiums for medical/dental/vision, STD, LTD, 401(k) with 50% match up to 3%, 15 PTO days, sick leave, 11 holidays
Skills & Requirements
Must-have
Bioanalytical Lab QA (GLP/FDA)
CLIA/CAP requirements
Quality Management System (QMS)
FDA inspection readiness
internal audits and inspection readiness
Nice-to-have
collaborative, science-driven environment
continuous improvement mindset
cross-functional collaboration
Key Requirements
7+ years of QA experience
Bachelor's or Master's degree
Experience supporting or leading FDA inspections
Familiarity with clinical pathology, bioanalytical, biomarker, or IHC-based workflows