Quality Laboratory Technician III - Histochemistry/Chemistry

Epredia • Kalamazoo, MI

79d • $43,000 - $70,000

About The Position

Be a part of a global team where what we do matters! At Epredia, we recognize that our talented employees are vital to our success. Our team is dedicated, our work is rewarding – both personally and professionally – because what we do matters. We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation. People – We win as a team. Customer – We deliver customer-centric solutions. Continuous Learning – We learn and always aim to be better. Innovation – We innovate every day. Results – Results matter for all of us. We are seeking a skilled and motivated Quality Laboratory Technician III - Histochemistry/Chemistry to join our Epredia team. As a Quality Assurance Laboratory Analyst, you will play a critical role in ensuring the quality and accuracy of our products through meticulous analysis, testing, and documentation. Your proficiency in histological techniques and chemical analysis will contribute to maintaining our high standards of product excellence and regulatory compliance.

Requirements

• 3+ years of relevant work experience.
• Associates degree.
• Histologist Certification (HT) preferred.
• Experience supporting a manufacturing environment.
• Must be willing to work with and around hazardous chemicals.
• Experience of working with FDA-regulated products desired (Medical Device/IVD preferred) (pharmaceutical, dietary supplement or food experience is acceptable).
• Knowledge of ISO13485 / FDA QSR 21 CFR Part 820 / 803 requirements preferred, 21 CFR Part 110, 111 or 211 is acceptable.
• Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously.
• 3+ years laboratory experience in an FDA-regulated laboratory.
• Proficient in MS applications (Excel, Word, Outlook).

Responsibilities

• Analyze chemical raw material samples.
• Analyze chemical bulk solution and finished goods samples.
• Maintain laboratory records (data integrity).
• Maintain laboratory histology instruments.
• Maintain a clean working environment.
• Perform laboratory and manufacturing instrument calibrations.
• Initiate, revise and implement instrument and test method validation.
• Review and write/revise laboratory SOP’s on a continuous basis.
• Analysis of customer complaints including written report.
• Perform product stability testing/studies.
• Complete project work as to support the organization (including sustaining engineering work).
• Participate in formulation development.
• Participate in review of risk analysis for product development.
• Lead and participate on Practical Process Improvement teams.
• Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management.
• Familiarity with Quality Systems regulations.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401k
• Holiday pay
• Vacation
• Annual discretionary bonus

What This Job Offers

• Job Type: Full-time
• Education Level: Associate degree
• Number of Employees: 1,001-5,000 employees