Sterility Assurance Lead – 2nd Shift QA

RXinsider LTD.; Sugar Land, Northern (TX, KY); Hybrid; USD 85,000 - 115,000; Full time

Benefits offered by this job

Comprehensive health benefits

401k with company match

Paid time off

22 days PTO + 8 holidays per year

Job summary

Quva in Sugar Land, TX is hiring a Supervisor, Sterility Assurance to oversee environmental and personnel monitoring, ensuring aseptic conditions and compliance with FDA 503B and CGMP standards. This full-time 2nd shift role supports lot release and provides training to staff in sterile techniques.

The ideal candidate will have a microbiology-related degree, 2–3 years in QA/CGMP, and at least 1 year in supervision.

Qualifications

• Bachelor’s degree in Microbiology, Life Science or related field.
• 2–3 years in Quality Assurance / cGMP / FDA-regulated industry.
• 1 year of supervisory or management experience.
• Experience training personnel on aseptic techniques and gowning.
• Knowledge of 503B CGMP and problem solving capabilities.
• Able to lift up to 50 lbs during shift.

Responsibilities

• Supervises EM/PM staff and provides development when appropriate.
• Ensures Sterility Assurance program standardization per Corporate Policies.
• Elevates QA decisions related to aseptic conditions in clean rooms.
• Reviews in-process EM/PM documents supporting lot release.
• Provides SME support and review of Deviations / Investigations.
• Maintains environmental monitoring program and interpret results.
• Trains personnel on aseptic and gowning techniques.
• Reviews records to ensure drug product quality standards.
• Maintains EM/PM records and testing equipment calibration.
• Assists in developing Sterility Assurance policies and procedures.
• Enforces personnel policies and procedures.

Skills

Environmental monitoring

Personnel monitoring

cGMP

FDA compliance

Supervisory experience

Education

Bachelor’s Degree in Microbiology or Life Science

Job description

Quva in Sugar Land, TX is hiring a Supervisor, Sterility Assurance to oversee environmental and personnel monitoring, ensuring aseptic conditions and compliance with FDA 503B and CGMP standards. This full-time 2nd shift role supports lot release and provides training to staff in sterile techniques.

The ideal candidate will have a microbiology-related degree, 2–3 years in QA/CGMP, and at least 1 year in supervision.