Quality Control Associate

Website Nanotherm Therapeutics Inc.

NOTE: This is an ON-SITE position in Wilmington, DE with no relocation and No Visa Sponsorships offered at this time.

Company Overview

Nanotherm Therapeutics Inc. is an innovative medical device company transforming localized cancer treatment through the use of magnetic nanoparticle technology. We pioneer NanoTherm therapy, a groundbreaking approach that uses superparamagnetic nanoparticles and an external magnetic field to selectively destroy tumor cells, offering new hope in oncology. Our team is passionate about advancing patient care through cutting edge science and transformative therapies, and we are looking for driven individuals to join us in this mission.

Job Summary

We are seeking a Quality Control (QC) Associate to support the end-to-end testing of our superparamagnetic iron oxide nanoparticle (SPION) suspension produced at our Delaware facility. This role is responsible for executing QC tests for raw materials, in-process samples, and final product. The associate will work under the supervision of Quality and is responsible for ensuring data integrity, instrument readiness, and regulatory compliance in accordance with FDA and ISO requirements.

Key Responsibilities

• Perform QC tests including pH, conductivity, solids content, iron concentration (photometric), particle size, and zeta potential.
• Sample and test raw materials, in-process products, and final products to ensure all results meet the defined specifications.
• Maintain detailed, traceable records and data logs in compliance with GDP and cGMP using our eQMS system.
• Coordinate external testing (e.g., sterility or advanced assays) with approved vendors.
• Review and approve sterility test results from our approved sterilization provider.
• Support investigations into non-conformances, out-of-spec, and out-of-tolerance results.
• Assist in the validation of new QC methods or updates to existing ones.
• Ensure proper sample handling, labeling, traceability, and storage.
• Manage vendor calibration of lab instruments and perform light internal calibrations when needed.
• Maintain a clean, safe laboratory environment and manage inventory of lab supplies.
• Collaborate with QA and production teams to support batch testing and timely product readiness.

Qualifications

• Bachelor’s degree in chemistry, Biochemistry, Materials Science, or a related technical field (required).
• Minimum 5 years of QC experience in a medical device or IVD lab.
• Strong understanding of FDA Medical Device Regulations, ISO 13485, and cGMP requirements for QC testing.
• Hands-on experience with DLS/zeta potential instruments, spectrophotometers, and wet chemistry.
• Skilled in interpreting test results and identifying anomalies or deviations.
• Excellent documentation and communication skills.
• Experience coordinating external calibration vendors and maintaining lab equipment.

Physical Requirements

• Ability to stand or sit for extended periods and perform repetitive tasks.
• Lift and move equipment or samples up to 25 lbs.
• Work safely with chemicals using appropriate PPE.
• Operate lab instruments with fine manual dexterity.

Work Environment

Work is performed in a laboratory setting at Nanotherm Therapeutics’ Delaware facility. This includes handling chemicals, operating sensitive instruments, and close coordination with the Production and Quality teams. Adherence to hygiene and safety standards is critical.

• Nanotherm Therapeutics is unable to provide visa sponsorships or paid relocation for this position.**

Equal Opportunity Statement

Nanotherm Therapeutics Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. We are committed to fostering an inclusive and diverse workforce.

Salary And Benefits

Competitive salary and benefits package.

Send Resumes with Letters of Interest to: ***email_hidden***

To apply for this job email your details to ***email_hidden***

NOTE: This is an ON-SITE position in Wilmington, DE with no relocation and No Visa Sponsorships offered at this time.

Salary And Benefits

Competitive salary and benefits package.

Send Resumes with Letters of Interest to: ***email_hidden***