Quality Specialist I

Location: Hanover, MD

Company: Noxilizer, Inc.

Industry: Biotechnology, Medical Devices, Pharmaceuticals, Life Sciences

About Noxilizer, Inc.

Noxilizer, Inc. is a pioneering biotech company based in Hanover, Maryland, specializing in next-generation room-temperature nitrogen dioxide (NO₂) sterilization technology. Our mission is to revolutionize sterilization in pharmaceutical, biotech, and medical device industries through safe, scalable, and innovative solutions. We are a fast-paced, collaborative team of scientists, engineers, and professionals who are passionate about quality, innovation, and impact.

As we continue to grow, we are seeking a Quality Specialist I to join our team and support our quality operations in maintaining compliance, advancing internal systems, and ensuring excellence across our manufacturing and laboratory environments.

Position Summary

The Quality Specialist I is an entry-level quality assurance and compliance role that supports day-to-day quality system activities in a regulated environment. This individual plays a key role in ensuring that Noxilizer’s products, services, and operations meet internal quality standards and comply with applicable regulations, including ISO 13485, FDA 21 CFR Part 820, and other relevant industry guidelines.

This role is ideal for someone detail-oriented, organized, and eager to grow their career in quality assurance within the life sciences or medical device industry.

Key Responsibilities:

• Assist in the maintenance and improvement of the company’s Quality Management System (QMS), including document control, training records, CAPAs, NCRs, and change controls
• Support internal audits, customer audits, and regulatory inspections through preparation and participation
• Perform review of batch records, quality documentation, and production reports to ensure compliance and accuracy
• Participate in deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPA)
• Support the management of controlled documents such as SOPs, forms, quality policies, and specifications
• Coordinate quality-related training activities and maintain accurate training records for all departments
• Track and trend quality metrics and provide periodic reports to Quality leadership
• Monitor calibration and preventive maintenance schedules to ensure timely completion
• Work closely with manufacturing, R&D, and operations teams to ensure quality is integrated into all processes
• Maintain up-to-date knowledge of regulatory changes and quality system best practices

Qualifications:

• Associate’s or Bachelor’s degree in Life Sciences, Biology, Chemistry, Engineering, or related field (required)
• 0–2 years of experience in a regulated environment (pharma, biotech, medical device preferred)
• Understanding of basic quality principles, cGMP, ISO 13485, and/or FDA 21 CFR Part 820 (training will be provided)
• Strong attention to detail and organizational skills
• Excellent written and verbal communication skills
• Ability to handle multiple tasks, prioritize effectively, and work independently or as part of a team
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint)

Preferred Qualifications

• Prior internship or co-op experience in Quality Assurance or Regulatory Affairs
• Familiarity with electronic QMS tools and document control software
• Experience participating in audits or regulatory inspections

Why Join Noxilizer?

• Be part of a growing biotech company delivering innovative sterilization solutions
• Hands-on experience with cutting-edge technology in a highly collaborative environment
• Opportunities for growth, mentorship, and advancement
• Competitive salary and benefits package including medical, dental, and vision insurance, PTO, and 401(k)
• Convenient location in Hanover, MD near major highways and public transportation

At Noxilizer, we are revolutionizing the sterilization industry with our ultra-low temperature nitrogen dioxide sterilization technology, providing significant advantages over traditional methods. We work with leading pharmaceutical, biotech, and medical device companies worldwide, offering opportunities for growth and development in a highly specialized field.

How to Apply:

If you’re ready to launch or grow your career in quality assurance and want to be part of a company that’s making a real difference in healthcare and life sciences, we encourage you to apply!

Job Type: Full-time

Pay: $55,000.00 – $62,500.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person