Quality Control Associate I/II — Assay Validation & QC

Valid8 Financial, Inc.; Florida; On-site; USD 60,000 - 90,000; Full time

Job summary

Valid8 Financial, Inc. is seeking a Quality Control Associate to transfer, execute, qualify and validate assays per ICH guidelines and perform in-process, routine testing for material characterization and product commercialization.

The role reports to the Manager, Quality Control, and involves vendor coordination, data review for release and stability, assay development support, and ensuring compliance with FDA GLPs, GMPs and GDPs.

Qualifications

• B.S. degree in a biological science or related field.
• GLP/GMP environment experience.
• 0–2 or 2–4 years QC experience (Level I/II) in a biotech setting.
• Advanced proficiency with immunology, molecular biology, and/or cell biology assays.
• Ability to evaluate assay methods according to ICH guidelines.
• Experience with assay validation and statistics is desirable.
• Strong written and verbal communication; detail oriented.

Responsibilities

• Perform routine testing including qPCR, ddPCR, SDS-PAGE, ELISA, and cell-based assays.
• Assist in management of external vendors for GLP and GMP testing.
• Review results for release, stability, and in-process testing.
• Support assay development and qualification activities; troubleshoot HSV and AAV assays.
• Support in-house QC through testing, data review, and reference materials development.
• Write and review protocols, transfer protocols, test methods, reports, SOPs, and Certificates of Tests.
• Ensure compliance with FDA regulations for GLPs, GMPs and GDPs.
• Other duties as assigned.

Skills

qPCR

ddPCR

SDS-PAGE

ELISA

Cell-based assays

Statistics

MS Office

Education

B.S. in biological science

Tools

Excel

PowerPoint

Word

Job description

Valid8 Financial, Inc. is seeking a Quality Control Associate to transfer, execute, qualify and validate assays per ICH guidelines and perform in-process, routine testing for material characterization and product commercialization.

The role reports to the Manager, Quality Control, and involves vendor coordination, data review for release and stability, assay development support, and ensuring compliance with FDA GLPs, GMPs and GDPs.