QA Lab Technician II: Histology & Quality Control (Onsite)

Epredia; Kalamazoo (MI); On-site; USD 55,000 - 75,000; Full time

Job summary

Epredia in Kalamazoo, MI is seeking a Quality Assurance Lab Technician II to join our fast-paced Quality Lab team. You will perform critical QA testing on raw materials and finished goods to support compliant product releases beneath ISO 13485 standards.

Work with R&D to test materials, optimize formulations, and ensure staining, embedding, and microtomy meet stringent criteria. Strong GDP/SOP/WIN compliance and QC experience are essential.

Qualifications

• Associate or Bachelor’s degree in Histotechnology, Medical Laboratory Science, Biology, Chemistry, or related field.
• HT (ASCP) or HTL (ASCP) certification is preferred but not required with equivalent industry experience.
• Minimum 2 years of experience in a clinical histology lab or regulated manufacturing QC environment.
• Proficient in manual staining, microtomy, embedding, and stain evaluation.

Responsibilities

• Test raw materials, in-process bulk chemical formulations, and finished products against release specifications.
• Perform manual staining exactly as IFU dictates to verify efficacy and visual quality.
• Utilize histology techniques (grossing, embedding, microtomy, slide prep) to test reagents and waxes.
• Record results in GDP/SOP/WIN-compliant manner.
• Collaborate with R&D to evaluate formulations for performance or cost.
• Maintain adherence to QMS requirements and participate in audits.
• Coordinate with manufacturing to minimize bottlenecks and ensure timely releases.

Skills

Manual staining

Microtomy

Embedding

Histology

Quality control

Education

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

Tools

ASCP HT/HTL certification

Job description

Epredia in Kalamazoo, MI is seeking a Quality Assurance Lab Technician II to join our fast-paced Quality Lab team. You will perform critical QA testing on raw materials and finished goods to support compliant product releases beneath ISO 13485 standards.

Work with R&D to test materials, optimize formulations, and ensure staining, embedding, and microtomy meet stringent criteria. Strong GDP/SOP/WIN compliance and QC experience are essential.