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, to help ensure compliance within the facility. After completing training, the specialist supports pharmaceutical product quality and safety by following precise procedures and ensuring medications meet applicable standards.

The position is based at the Sugar Land, Texas site and follows a set Monday-through-Friday second-shift schedule from 2:00 PM to 10:30 PM. It is a safety-sensitive role 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.
• Ability and willingness 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 and cGMP processes.

Responsibilities

• Ensure compliance with QuVa Pharma’s Standard Operating Procedures (SOPs) and Quality Management System (QMS).
• Schedule and proctor media fills.
• Read media aseptic process simulations and Environmental/Personnel Monitoring (EM/PM) plates, and account for all units.
• Perform EM/PM sampling and maintain EM/PM records.
• Periodically review EM/PM data to identify potential trends.
• Provide personnel 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.
• Work with area supervision to provide quality assurance oversight for adherence to current Good Manufacturing Practices (cGMPs).
• Identify and resolve events that may affect product and process quality in a timely manner, using appropriate discretion.
• Provide technical expertise on current processes and oversee department personnel training 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

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

What This Job Offers

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