Job Details

Job Title: Quality Control Associate – Reagent Manufacturing

Location: Tucson, AZ (Onsite)

Job Type: Contract (12 Months)

Pay Rate: Up to $25.75/hr on W2

Company Overview

Leading global biotechnology organization operating in diagnostics and life sciences, focused on delivering high-quality products in regulated environments including cGMP and ISO 13485.

Job Description

The Quality Control Associate – Reagent Manufacturing will support raw material, in-process, and finished goods testing in a regulated laboratory environment. This role is responsible for maintaining quality documentation, performing laboratory testing, and ensuring compliance with cGMP, ISO, and regulatory standards.

Key responsibilities include executing laboratory testing, maintaining batch records, supporting investigations such as OOS, and ensuring inspection readiness. The role also involves equipment maintenance, environmental monitoring, inventory control, and collaboration with cross-functional teams to support quality and manufacturing operations.

Key Responsibilities

• Perform testing of raw materials, in-process, and finished goods
• Maintain and review batch records and QC documentation
• Support OOS, deviation, and non-conformance investigations
• Ensure compliance with cGMP, ISO 13485, and regulatory standards
• Conduct environmental monitoring and lab maintenance
• Perform equipment calibration and routine maintenance
• Manage lab inventory, supplies, and cycle counts
• Assist in validations and process improvements

Required Qualifications

• High School Diploma with 7+ years experience OR
• Associate Degree with 3+ years experience OR
• Bachelor's Degree in Life Sciences (entry-level acceptable)
• Hands-on laboratory experience
• Knowledge of GMP, GLP, or ISO environments
• Strong documentation and data analysis skills
• Experience with pipetting and basic lab techniques

Preferred Qualifications

• Experience in reagent manufacturing
• Exposure to ISO 13485 or medical device environment
• Experience handling biohazardous or chemical reagents
• Knowledge of Lean / 6S methodologies