QC Technician

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.



These industries would translate:

• 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

LAL / Endotoxin Testing

• LAL testing, Limulus Amebocyte Lysate, Endotoxin testing, Gel clot LAL, Chromogenic LAL, Turbidimetric LAL, Endotoxin quantification, USP <85> compliance

Environmental Monitoring (EM)

• Environmental monitoring (EM), Viable air monitoring, Non viable particle counting, Cleanroom monitoring, Surface sampling, Contact plate testing, Settle plates, Microbial monitoring, ISO classified cleanroom testing, Aseptic environment monitoring

Analytical Testing

• 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

Validation & Calibration

• Process validation, IQ/OQ/PQ testing, Protocol execution, Equipment qualification, Calibration procedures, Calibration documentation, Instrument verification, Method validation support

Documentation & Compliance

• GMP testing, GDP documentation, Good Documentation Practices, ISO 13485 documentation, FDA QSR compliance, Batch record review, Data verification, OOS investigations, CAPA support

QC Micro / Medical Device

• QC microbiology, Sterile product testing, Medical device QC testing, Biocompatibility related testing, Sterility controls, ISO 13485 testing environment, FDA regulated lab testing

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific