QA Lab Technician II: Histology & Materials Quality

1101 Richard-Allan Scientific LLC; Kalamazoo (MI); On-site; USD 52,000 - 70,000; Full time

Job summary

Ascensia Diabetes Care is seeking a skilled Histology Lab Technician II to join our Quality Lab in Kalamazoo, MI. This onsite role supports release testing of materials and finished products with strict adherence to ISO 13485 and GDP standards.

The ideal candidate has a histology background, ASCP HT/HTL preferred, 2+ years in a regulated lab, and strong staining, embedding, and microtomy skills to ensure product quality and regulatory compliance.

Qualifications

• Associate or Bachelor’s degree in Histotechnology, Medical Laboratory Science, Biology, or Chemistry.
• HT (ASCP) or HTL (ASCP) certification preferred but not required with equivalent industry experience.
• 2+ years of experience in a clinical histology lab or regulated manufacturing quality control environment (ISO 13485, FDA21 CFR Part 820, or GMP).
• Strong proficiency in manual staining, microtomy, 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.

Responsibilities

• Test raw materials, in-process formulations, and finished products against release specifications.
• Perform manual staining techniques exactly as prescribed by Instructions for Use to verify product efficacy and visual quality.
• Utilize standard histology techniques (grossing, embedding, microtomy, and slide preparation) to test reagents and waxes.
• Record all test results accurately in GDP, SOPs, and WINs.
• Collaborate with R&D scientists to evaluate and tweak formulations for performance or cost-efficiency.
• Test and validate new or alternative raw materials to ensure they meet standards.
• Maintain adherence to QMS requirements and participate in audits as needed.
• Coordinate with manufacturing to minimize bottlenecks and support timely releases.

Skills

Manual staining

Microtomy

Embedding

Histology QC

Education

Associate or Bachelor’s degree in Histotechnology, Medical Laboratory Science, Biology, or Chemistry

Job description

Ascensia Diabetes Care is seeking a skilled Histology Lab Technician II to join our Quality Lab in Kalamazoo, MI. This onsite role supports release testing of materials and finished products with strict adherence to ISO 13485 and GDP standards.

The ideal candidate has a histology background, ASCP HT/HTL preferred, 2+ years in a regulated lab, and strong staining, embedding, and microtomy skills to ensure product quality and regulatory compliance.