Supervisor, Sterility Assurance 2nd Shift
Listed on 2026-07-05
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
Supervisor, Sterility Assurance 2nd Shift Job Category
8000-Quality
Requisition NumberSUPER
005965
- Posted :
July 1, 2026 - Full-Time
- On-site
Showing 1 location
TX - Sugar Land 1075
1075 W Park One Dr #100
Sugar Land, TX 77478, USA
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.
What the Supervisor, Sterility Assurance Does Each Day:- 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 upscale 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 EM/PM records
- Responsible for maintaining all testing equipment in compliance, calibration, and certification.
- Assists in developing policies and procedures related to Sterility Assurance
- Enforces applicable personnel policies and procedure
- 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
- 1 year of supervisory or management experience
- 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;
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