QC Analyst II-Microbial Control

About the role

This role supports the testing of in-process and final product samples to ensure the safety and quality of drug products. The position involves microbiological testing, environmental and utility monitoring, and delivering accurate results to meet manufacturing timelines.

Responsibilities

• Perform microbiological testing for in-process, release, and stability samples
• Support environmental and utility monitoring, including HVAC and facility sampling
• Review and document test results in accordance with GMP and data integrity standards
• Use laboratory systems and software to record and manage data
• Identify deviations and support investigations when results fall outside expected ranges
• Ensure compliance with cGMP, GDP, and data integrity requirements in all tasks
• Participate in routine lab activities, including sample handling and documentation

Requirements

• Associate’s degree in Microbiology, Biochemistry, or a related science field
• Experience in a GMP or regulated laboratory environment preferred
• Ability to interpret data and identify trends or deviations
• Strong written and verbal communication skills
• Attention to detail and strong organizational skills
• Prior laboratory experience, familiar with aseptic techniques and strong documentation practices, preferred
• Comfortable working in cleanroom environments, including performing physical tasks such as climbing ladders when needed

Qualifications

• Competitive pay and performance-based compensation
• Medical, dental, and vision insurance
• A supportive and inclusive work environment
• Opportunities for career growth and development
• Hands-on training and skill-building
• A collaborative and team-focused laboratory environment

Skills

• Microbiology
• Biochemistry
• Data integrity
• GMP/GDP compliance
• Laboratory systems and software
• Aseptic techniques
• Cleanroom environments

Benefits

• Medical, dental, and vision insurance
• A supportive and inclusive work environment
• Opportunities for career growth and development
• Hands-on training and skill-building
• A collaborative and team-focused laboratory environment

Pay

• Competitive pay and performance-based compensation

Schedule

• Sunday–Wednesday schedule
• Working hours from 7:30 PM to 5:30 AM