Quality Assurance Laboratory Technician II

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

Make a Meaningful ImpactReady to join a team where your work makes a daily difference in healthcare?Epredia is a global leader in precision cancer diagnostics solutions. In fact, every second, our products are used 48 times in labs and medical facilities around the world.We are a proud member of PHC Group, a global collection of companies committed to delivering precision technology for the future of healthcare, from specialized medical equipment to health IT systems to research tools.Title: Quality Assurance Lab Technician IILocation: Kalamazoo, MIWork Arrangement: Onsite - 7:00AM - 3:30PM M-FEmployment Type: Full-TimeThe OpportunityWe 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.How You'll Make An ImpactTest 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.Bring Your ExpertiseAssociate 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.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.#LI-HH1#DE-EPREDIAReady to Make an Impact?If this opportunity aligns with your skills and career goals, we'd love to hear from you. Apply today and take the next step in your career with us.Building an Inclusive CultureWe are a company that brings the best people together and leverages their varying backgrounds, ideas, and points of view to invent on behalf of all customers. We are committed to equal employment opportunity for all individuals, without regard to race, color, national origin, ancestry, sex, age, religion, physical or mental disability, medical condition, veteran status, marital status, pregnancy, sexual orientation, gender identity, genetic information, or any other protected classes which may exist under applicable federal, state, or local law.