Quality Assurance Laboratory Technician II

Epredia • Kalamazoo, MI

9d • Onsite

About The Position

Epredia is a global leader in precision cancer diagnostics solutions. We are seeking a skilled and detail-oriented Histologist to join our fast-paced Quality Lab team. In this role, you will perform critical quality control testing on raw materials, bulk formulations, and finished goods to ensure compliance with ISO 13485 standards before products are released to consumers. Beyond routine quality control, you will collaborate directly with our Research and Development (R&D) team to test new raw materials and help optimize product formulas.

Requirements

• 2+ years of experience in a clinical histology lab or a regulated manufacturing quality control environment (ISO 13485, FDA21 CFR Part 820, or GMP).
• Strong proficiency in manual staining, microtomy (cutting), and embedding.
• Experience evaluating stain quality, color intensity, and tissue morphology under a microscope.
• Familiarity with a wide range of histological reagents, fixatives, and solvents.

Nice To Haves

• Associate or Bachelor’s degree in Histotechnology, Medical Laboratory Science, Biology, Chemistry, or a related scientific field is preferred.
• HT (ASCP) or HTL (ASCP) certification is highly preferred but not required with equivalent industry experience.

Responsibilities

• Test raw materials, in-process bulk chemical formulations, and finished products against strict release specifications.
• Perform manual staining techniques exactly as prescribed by Instructions for Use (IFU) documents to verify product efficacy and visual quality.
• Utilize standard histology techniques (grossing, embedding, microtomy, and slide preparation) to test the functionality of our manufacturing reagents and waxes.
• Record all test results accurately in compliance with Good Documentation Practices (GDP), Standard Operating Procedures (SOPs), and Work Instructions (WINs).
• Work alongside R&D scientists to evaluate and tweak chemical formulations for improved performance or cost-efficiency.
• Test and validate new or alternative raw materials to ensure they meet performance and regulatory standards.
• Maintain strict adherence to medical device quality management system (QMS) requirements and participate in internal/external audits as needed.
• Coordinate closely with the manufacturing team in a high-throughput environment to minimize production bottlenecks and support timely product releases.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree