Sterility Assurance Lead, 2nd Shift

RXinsider LTD.; Sugar Land (TX); On-site; USD 78,000 - 110,000; Full time

Benefits offered by this job

Set, full-time schedule

Health and wellness benefits

401k with company match

Paid time off

Job summary

Quva Supervisor, Sterility Assurance leads environmental and personnel monitoring, ensuring Sterility Assurance programs align with corporate policies and cGMP standards. Oversees QA decisions and maintains EM/PM records to support timely lot release.

You will train staff in aseptic techniques, review deviations, and help sustain a culture of quality across the manufacturing site in Sugar Land, TX. This is a full-time, safety-sensitive role requiring upholding FDA CGMP requirements.

Qualifications

• Bachelor's degree in Microbiology or Life Sciences required.
• 2-3 years in Quality Assurance / cGMP / FDA regulated industry.
• 1 year of supervisory experience preferred.
• Experience training personnel on aseptic techniques and gowning.
• Knowledge of 503B CGMP requirements and problem solving.

Responsibilities

• Supervises environmental and personnel monitoring (EM/PM) staff and provides development.
• Ensures standardization of Sterility Assurance programs with Corporate Policies.
• Escalates QA decisions related to aseptic conditions during manufacturing.
• Performs in-process review of EM/PM documents to support on-time lot release.
• Provides SME review of Deviations / Investigations and maintains EM/PM records.
• Trains personnel on aseptic techniques and gowning; ensures records accuracy.
• Reviews records to verify drug product quality standards are met.
• Maintains compliance with FDA 503B and CGMP regulations; protects safety and quality.

Skills

Quality Assurance

cGMP knowledge

Supervisory experience

Aseptic training

FDA regulations

Environmental monitoring

Education

Microbiology degree

Tools

LIMS software

Job description

Quva Supervisor, Sterility Assurance leads environmental and personnel monitoring, ensuring Sterility Assurance programs align with corporate policies and cGMP standards. Oversees QA decisions and maintains EM/PM records to support timely lot release.

You will train staff in aseptic techniques, review deviations, and help sustain a culture of quality across the manufacturing site in Sugar Land, TX. This is a full-time, safety-sensitive role requiring upholding FDA CGMP requirements.