Quality Assurance Laboratory Technician II - Histochemistry/Chemistry

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 Assurance Laboratory Technician II - Histochemistry/Chemistry with expertise in Histology and Chemistry to join our Epredia team. As a Quality Assurance Laboratory Technician II - Histochemistry/Chemistry, 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.

Location: Onsite Kalamazoo, MI

What you will be doing:

• 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.

Skills you will need:

• 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

• Less than 5% travel (US & International)

• 3+ years laboratory experience in an FDA-regulated laboratory

• Proficient in MS applications (Excel, Word, Outlook)

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TO ALL RECRUITMENT AGENCIES: Epredia does not accept unsolicited third-party resumes.

Building an Inclusive Culture: We 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.