Quality Control Associate

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

We are seeking a highly motivated Quality Control Associate with at least 3 years of laboratory experience in a regulated biotechnology, cell therapy, or life sciences environment. The successful candidate will support Quality Control (QC) and Quality Assurance (QA) activities through analytical testing, assay development, documentation, and compliance with ISO 9001 standards and established Standard Operating Procedures (SOPs).

This role requires hands‑on experience with mammalian cell culture, stem cell culture, flow cytometry, molecular and cell-based assays, aseptic techniques, and quality‑focused laboratory operations.

Key Responsibilities

• Perform in process and lot‑release QC testing and characterization of stem cell derived products using validated methods.
• Maintain and culture stem cells utilizing aseptic techniques, including cell used as assay controls and reference material.
• Conduct and analyze assays including Flow Cytometry, qPCR, ELISA, Immunocytochemistry (ICC)
• Analyze and report results (FlowJo, GraphPad Prism, ImageJ) and compile data for review and Certificate of Analysis preparation.
• Execute sample preparation, testing, data analysis, and documentation activities.
• Draft and revise SOPs, test methods, and forms for the methods you run, for review and approval by others.
• Ensure compliance with QA/QC requirements and company procedures.
• Investigate deviations, document non‑conformances, and support corrective and preventive actions (CAPA).
• Maintain logs for deviations, CAPAs, and change controls, and report open items and aging to the Director of Manufacturing and Quality.
• Help prepare records and evidence for internal audits.
• Keep QC equipment in service: routine maintenance, calibration and service scheduling, and equipment records.
• Manage QC reagent and consumable inventory, including lot tracking, expiry, and reorder triggers.
• Participate in method optimization, troubleshooting, and continuous improvement initiatives, including recurring assay problems and suggest practical fixes to existing methods
• Collaborate with cross-functional teams to support product development and release testing activities.
• Maintain accurate, timely, and compliant laboratory documentation.

Qualifications

Required:

• Master's degree in biology, Cell Biology, Biotechnology, Molecular Biology, Biochemistry, or a related scientific field.
• Minimum 3 years of laboratory experience in an industry and/or research setting.
• At least 2 years of that experience in industry, ideally running routine testing in a QC, CRO, or other regulated or quality‑managed lab.
• Hands‑on experience with iPSC, Stem cell culture, Flow cytometry, qPCR, ELISA, Immunocytochemistry (ICC), Aseptic techniques
• Experience writing and revising SOPs and technical documents.
• Working knowledge of Good Documentation Practices and data integrity expectations.
• Track record of executing written procedures precisely and repeatedly, with low error rates.
• Strong organizational, analytical, and problem‑solving skills.
• Excellent verbal and written communication skills.

Preferred:

• Exposure to document control, change control, deviations, or CAPA within a quality system (ISO 9001, GMP, or GLP).
• Experience with a quality management system.
• Experienced working in a fast‑paced work environment.