Sterility Assurance Specialist 2nd Shift

Quva • Sugar Land, TX

1d • Onsite

About The Position

The Sterility Assurance Specialist oversees and performs Quality Assurance aspects of Sterility Assurance, including Environmental/Personnel Monitoring (EM/PM), to help ensure facility compliance and the safety, efficacy, and quality of pharmaceutical products. After completing training, the specialist supports aseptic process simulations, monitoring, quality reviews, investigations, personnel training, and production oversight in accordance with company procedures and applicable current Good Manufacturing Practices (cGMPs).

This is a full-time, onsite role at the Sugar Land, Texas location, on a consistent Monday–Friday second-shift schedule from 2:00 PM to 10:30 PM. It is a safety-sensitive position that may be subject to random drug testing in accordance with applicable laws.

Requirements

• High school diploma or equivalent.
• Successfully complete a drug and background check.
• Able and willing to walk, stoop, stand, bend, and lift up to 50 pounds throughout each shift, with or without reasonable accommodation.
• At least 18 years of age.
• Strong Microsoft Word and Excel skills.
• Knowledge of sterile pharmaceutical manufacturing technologies and FDA and other applicable GMP regulations for sterile products.
• Currently authorized to work in the United States on a full-time basis; QuVa is unable to sponsor applicants for work visas.

Nice To Haves

• Bachelor’s degree in life science or a related field.
• At least 1 year of experience at QuVa Pharma.
• At least 2 years of experience in Quality Assurance, sterile compounding, and/or a GMP production facility.
• At least 2 years of experience with FDA-regulated operations (cGMP processes).
• Detail-oriented, with strong verbal and written communication skills.
• Able to support open communication, participation, and information-sharing within and between teams.
• Able to help develop a climate of quality and safety by identifying and monitoring quality and safety standards.
• Decisive and goal-oriented, with strategic problem-solving skills.
• Accountable, energetic, able to multitask, and able to work in a fast-paced, quality-focused environment.
• Able to motivate others, share knowledge, build high-performing teams, show respect, and provide constructive feedback.

Responsibilities

• Ensure compliance with QuVa Pharma Standard Operating Procedures (SOPs) and the Quality Management System (QMS).
• Schedule and proctor media fills.
• Read media aseptic process simulation and Environmental/Personnel Monitoring (EM/PM) plates and account for all units.
• Perform EM/PM sampling and maintain EM/PM records.
• Periodically review environmental and personnel monitoring data to identify potential trends.
• Provide training support on appropriate aseptic and gowning techniques, including conducting Compounder Competency Assessments.
• Support sterility investigations, including EM/PM excursions, and review deviations and investigations.
• Provide Quality Assurance oversight in coordination with area supervision to support adherence to current Good Manufacturing Practices (cGMPs).
• Identify and resolve events that could affect product or process quality in a timely manner, using appropriate discretion.
• Maintain technical expertise in current processes and oversee training of department personnel on new processes.
• Review routine manufacturing, environmental monitoring, and quality control data for in-process and finished products.
• Evaluate batches and products for compliance with defined specifications.
• Sample, inspect, and control commercial product labels.
• Review and approve shipping documentation for commercial products.

Benefits

• Comprehensive health and wellness benefits, including medical, dental, and vision coverage.
• 401(k) retirement program with company match.
• 17 paid days off plus 8 paid holidays per year.
• Set, full-time, consistent work schedule.
• Career advancement opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED