QA Lab Specialist: ISO/GMP QC & Data Analysis

Filtration Group; Louisville (CO); On-site; USD 60,000 - 65,000; Full time

Benefits offered by this job

Health insurance

Paid Parental Leave

401k with Company Matching

Family leave

Health and wellness benefits

Job summary

Molecular Products, Inc is seeking a Quality Assurance Lab Specialist in the Louisville/Denver area who is a U.S. Person. The role involves QA testing, data analysis, compliance with FDA, GMP, ISO, and lab operations including GC instrumentation and sample generation.

The position offers salary between $60,000 and $65,000 with benefits such as health insurance, paid parental leave, 401k matching, and family leave, in a dynamic environment post-merger with Parker Hannifin.

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
• Ability to create lab scale sample generation.
• 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.
• Final Product Release – review final product data for conformance to requirements.
• Incoming Inspection – sample and inspect incoming material for conformance to requirements
• Manage Non-conforming material and deviations for assigned products.
• Reports on product performance trends proactively.

Skills

Analytical skills

Problem-solving

Safety oriented

Excellent communication

Education

Bachelor’s degree in science

Tools

MS Office

Job description

Molecular Products, Inc is seeking a Quality Assurance Lab Specialist in the Louisville/Denver area who is a U.S. Person. The role involves QA testing, data analysis, compliance with FDA, GMP, ISO, and lab operations including GC instrumentation and sample generation.

The position offers salary between $60,000 and $65,000 with benefits such as health insurance, paid parental leave, 401k matching, and family leave, in a dynamic environment post-merger with Parker Hannifin.