QC Technician

Overview

Job Title: Quality Control (QC) Technician
Location: Greater Jersey City, NJ (On-Site)
Hours: Monday–Friday, 9:00 AM – 5:00 PM
Salary: $60,000–$70,000 annually (based on experience)

Position Summary

The Quality Control (QC) Technician will perform laboratory testing and quality control activities to ensure products meet internal specifications and regulatory requirements. This includes testing raw materials, in process samples, and finished products; executing LAL (endotoxin) testing; conducting environmental monitoring; supporting validation work; and overseeing instrument calibration. This is a hands on role in a GMP regulated environment.

Key Responsibilities

• Perform testing on raw materials, in-process samples, and finished products per approved procedures.
• Conduct LAL (Limulus Amebocyte Lysate) endotoxin testing on finished goods and process samples.
• Perform environmental monitoring (viable and non viable) in classified cleanroom areas.
• Support process validation activities and documentation. Manage calibration activities, including scheduling, tracking, and coordinating services.
• Maintain accurate and compliant documentation according to GMP, FDA, and ISO 13485 standards.
• Review and verify laboratory data for accuracy and adherence to specifications.
• Participate in deviations, OOS investigations, and corrective action processes.
• Maintain audit-ready laboratory conditions with strong housekeeping practices.
• Contribute to continuous improvement initiatives within the quality control function.

Qualifications

• Associate’s or Bachelor’s degree in Biology, Chemistry, Microbiology, or related field.
• 1–3 years of QC experience in medical device, pharmaceutical, or biotechnology environments preferred.
• Experience with LAL testing, environmental monitoring, and analytical techniques (pH, conductivity) preferred.
• Knowledge of GMP, GLP, FDA QSR, and ISO 13485 requirements.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities.
• Proficiency in Microsoft Office (Excel, Word); LIMS experience is a plus.

Benefits

A comprehensive benefits package and opportunities for long-term professional growth are offered.

Industries / Related Experience

• Pharmaceutical Manufacturing (injectables, biologics, sterile drug products) Biotechnology (cell therapy, gene therapy, biologic manufacturing)
• Medical Device Manufacturing (sterile devices, Class II & III devices)
• Regenerative Medicine (PRP/PRF kits, tissue engineering)
• Clinical Diagnostics / Diagnostic Kits
• Sterile Compounding & Aseptic Processing Contract
• Testing Laboratories (QC Micro, Analytical Labs)
• Dialysis Products & Sterile Water Systems
• Veterinary Pharmaceuticals
• Biologics IVF and Reproductive Health Laboratories
• Tissue Banks & Blood Component Processing

Endotoxin & Environmental Testing Details

• LAL testing, Limulus Amebocyte Lysate, Endotoxin testing, Gel clot LAL, Chromogenic LAL, Turbidimetric LAL, Endotoxin quantification, USP compliance
• Environmental monitoring (EM), Viable air monitoring, Non viable particle counting, Cleanroom monitoring, Surface sampling, ISO classified cleanroom testing

Analytical & Compliance Focus

• Conductivity testing, pH testing, Osmolality testing, Physical inspection, Visual inspection, Sample integrity evaluation, In process testing, Finished product testing, Raw material testing, QC analytical testing
• Process validation, IQ/OQ/PQ testing, Protocol execution, Equipment qualification, Calibration documentation, Instrument verification, Method validation support
• GMP testing, GDP documentation, Good Documentation Practices, ISO 13485 documentation, FDA QSR compliance, Batch record review, Data verification, OOS investigations, CAPA support

Compliance Note

System One and its subsidiaries are equal opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, or any other characteristic protected by applicable law.