Quality Technician II

Summary of Position

The Quality Technician II performs chemical, physical, and instrumental testing of raw materials, in-process samples, and finished products to ensure product quality and compliance. This role supports manufacturing operations through timely analysis, accurate documentation, equipment maintenance, and effective communication of results. The position operates on a rotating 12-hour shift schedule.

Key Responsibilities

• Perform in-process, raw material, stability, returned goods, and finished product testing.
• Conduct laboratory analyses using approved procedures and GMP-compliant techniques.
• Accurately document test results and maintain laboratory records.
• Report analytical results in a timely manner through approved systems.
• Prepare standards, reagents, and solutions required for testing.
• Troubleshoot and perform routine maintenance on laboratory equipment.
• Support investigations, problem-solving activities, and continuous improvement initiatives.
• Assist with method validations, equipment qualifications, and non-routine analytical work as needed.
• Maintain a safe, organized work environment and support 5S initiatives.
• Train and assist team members as needed.
• Perform other duties as assigned.

Qualifications

Education

• Associate’s or Bachelor’s degree in Chemistry, Biology, Life Sciences, or a related scientific field preferred.
• Relevant experience may be considered in lieu of a degree.

Experience

• 1-3 years of laboratory experience, preferably within a pharmaceutical manufacturing environment.
• Knowledge of cGMP regulations preferred.

Skills & Competencies

• Basic laboratory techniques, instrumentation, and computer proficiency.
• Strong attention to detail and recordkeeping skills.
• Ability to perform basic mathematical calculations.
• Strong problem-solving, prioritization, and organizational skills.
• Effective written and verbal communication skills.
• Ability to make sound technical decisions and work independently.
• Ability to distinguish colors as required for laboratory testing.

Working Conditions

• Work primarily in an analytical laboratory environment.
• Exposure to chemicals and laboratory equipment common to pharmaceutical manufacturing.
• Ability to lift and transport laboratory materials as needed.
• Must be able to wear required PPE.
• Must be able to work a rotating 12-hour shift schedule (7:00 AM-7:00 PM / 7:00 PM-7:00 AM), including overtime as needed.