Supervisor, Sterility Assurance 2nd Shift

Our Supervisor, Sterility Assurance plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include supervising Quality Assurance aspects of sterility assurance including environmental and personnel monitoring teams ensuring compliance within the facility.

Operates within the legal and regulatory compliance, producing a quality product. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

This is a full-time role for our 2nd shift, working Monday through Friday from 2:00 PM to 10:30 PM. This is a set, consistent schedule with minimum overtime requirements and based on site in our Sugar Land, TX location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.

• Supervises all environmental and personnel monitoring (EM/PM) staff providing learning and development where appropriate

• Ensures standardization of site Sterility Assurance program with respect to Corporate Policies

• Ability to escalate QA decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations

• Responsible for timely and accurate in process review of EM/PM documents supporting lot release on time

• Provides SME support and review of Deviations / Investigations

• Maintains environmental monitoring program including environmental and personnel monitoring results that exceed alert or action limits and interpreting results

• Provides training support for personnel on appropriate aseptic techniques and gowning techniques

• Periodically review records to verify that quality standards for each drug product is met

• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws

• Responsible for maintaining all testing equipment in compliance, calibration, and certification.

• Assists in developing policies and procedures related to Sterility Assurance

• Work to create an environment of open communication, participation, and information-sharing within and between teams within Quality Assurance and throughout facility

• Are detail-oriented with strong verbal and written communications skills

• Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards

• Act decisively with purposeful pursuit of goals or objectives, and thinks strategically in terms of solutions

• Drive achievement, expresses energy, shows accountability, ability to multi-task and work in a fast-paced, quality-rich environment

• Motivate others, share knowledge, build high performing teams, show respect towards others, and give constructive feedback

• Bachelor’s Degree in Microbiology, Life Science or another related field

• 2-3 years prior experience in Quality Assurance / cGMP / FDA regulated industry

• Experience training personnel on aseptic techniques and appropriate gowning techniques

• Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP’s and have demonstrated strength in problem solving and resolution

• Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation

• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

• Understanding of process flows, gap assessments and analysis of data to drive improvement

Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care.

Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more.

Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.