Stem Cell QC Specialist - Assays & Compliance

Trailhead Biosystems; Beachwood (OH); On-site; USD 60,000 - 90,000; Full time

Job summary

Trailhead Biosystems seeks a highly motivated Quality Control Associate with 3+ years of lab experience in regulated biotech. The role supports QC/QA activities including analytical testing, assay development, and documentation to ensure ISO 9001 compliance.

Candidate will perform mammalian cell culture, flow cytometry, qPCR, ELISA, ICC, and related assays, while drafting SOPs and maintaining data integrity.

Qualifications

• Master's degree in biology or related field.
• 3+ years of laboratory experience in regulated biotech environment.
• Experience with QC/QA in a regulated lab (ISO 9001, GMP, or GLP) preferred.
• Hands-on iPSC or stem cell culture experience; flow cytometry and molecular assays.
• Experience writing/revising SOPs and technical documents.
• Knowledge of Good Documentation Practices and data integrity expectations.
• Strong organizational, analytical, and communication skills.
• Capable of following procedures with high accuracy and low error rate.

Responsibilities

• Perform in-process and lot-release QC testing of stem cell-derived products.
• Culture stem cells using aseptic techniques and manage controls.
• Conduct assays: Flow Cytometry, qPCR, ELISA, ICC; report results for COA preparation.
• Draft and revise SOPs and test methods for review and approval.
• Ensure QA/QC compliance and document deviations/CAPA actions.
• Maintain equipment logs, inventory, and calibrations.
• Collaborate with cross-functional teams for development and release testing.
• Maintain accurate, timely laboratory documentation.

Skills

Analytical thinking

Organizational skills

Problem-solving

Communication skills

Education

Master's degree in biology or related field

Tools

Flow Cytometry

qPCR

ELISA

Immunocytochemistry

Job description

Trailhead Biosystems seeks a highly motivated Quality Control Associate with 3+ years of lab experience in regulated biotech. The role supports QC/QA activities including analytical testing, assay development, and documentation to ensure ISO 9001 compliance.

Candidate will perform mammalian cell culture, flow cytometry, qPCR, ELISA, ICC, and related assays, while drafting SOPs and maintaining data integrity.