QA Lab Specialist I - Precision Testing & ISO Compliance

Molecular Products; Louisville (CO); On-site; USD 60,000 - 65,000; Full time

Benefits offered by this job

Health insurance

Health and wellness benefits

401k with Company Matching

Family leave

Paid Parental Leave

Job summary

Molecular Products, Inc. is hiring a Quality Assurance Lab Specialist I for the Louisville/Denver area. This role supports QA testing, data analysis, and compliance with FDA, GMP, and ISO standards in a lab setting.

Strong analytical skills and attention to detail are essential as you perform tests, manage equipment, and contribute to release decisions. Qualified candidates hold a science degree and QA lab experience.

Qualifications

• Bachelor’s degree in science, chemistry, bio-chemistry, chemical engineering, related or equiv. QA laboratory experience.
• Strong analytical and problem-solving skills.
• Safety oriented.
• Knowledge of ISO 9001 and/or ISO 13485 Quality Management System Requirements
• MS Office - Beginner to intermediate knowledge in Word, Excel and Access
• Excellent written and verbal communication skills

Responsibilities

• Performs quality control tests following procedures including adsorbent performance using challenge gases, toxic gases.
• Tracks and handles toxic gases in compliance with local laws and regulations, including the shipping and receiving of items.
• Operate GC’s and associated equipment for the physical properties (moisture content, particle size distribution, apparent density)
• Must be comfortable performing statistical data analysis, maintaining test control charts
• Follows process workflow and safety guidelines and protocols.
• Ability to complete basic preventive maintenance, equipment cleaning, work space cleaning, equipment calibration as required
• Ensure compliance with company policies and business practices including FDA Regulations, GMP, and ISO Medical Device Quality System Requirements.
• Investigate and troubleshoot product or production issues
• Develop corrective actions, solutions and improvements when necessary.
• Comfortable working in a lab environment.

Skills

Strong analytical and problem-solving

Safety oriented

MS Office (Word, Excel, Access)

Education

Bachelor’s degree in science/chemistry/biochemistry/chemical engineering

Tools

GCs

Lab calibration tools

MS Office

Job description

Molecular Products, Inc. is hiring a Quality Assurance Lab Specialist I for the Louisville/Denver area. This role supports QA testing, data analysis, and compliance with FDA, GMP, and ISO standards in a lab setting.

Strong analytical skills and attention to detail are essential as you perform tests, manage equipment, and contribute to release decisions. Qualified candidates hold a science degree and QA lab experience.