Sterility Assurance Technical Specialist
About The Position
Join our QC Microbiology team where you’ll play a critical role in maintaining environmental monitoring excellence across our sterile manufacturing operations. This individual contributor position reports to the QC Microbiology Manager and offers the opportunity to impact product quality and patient safety through rigorous data analysis and regulatory compliance. As the Sterility Assurance Technical Specialist, you will be responsible for performing comprehensive trending analysis of environmental monitoring data for routine surveillance programs and specialized projects such as EMPQs. You will collaborate with multifunctional teams, support deviation investigations, and ensure all work meets FDA, EMA, and Health Canada requirements while following industry best practices from USP, PDA, and ISPE.
Requirements
- Bachelor’s degree in Microbiology, Biology, Chemistry, or related scientific discipline, or equivalent experience
- Minimum 2-3 years of experience in pharmaceutical microbiology, quality control, or related GMP environment
- Working knowledge of FDA, EMA, and Health Canada regulatory requirements for environmental monitoring
- Proficiency in data analysis tools (e.g., Excel, statistical software) and trending methodologies
- Strong technical writing skills with attention to detail and accuracy
- Ability to work independently and collaboratively in a fast-paced environment
Nice To Haves
- Experience with sterile manufacturing environments and aseptic processes
- Familiarity with industry guidance documents for environmental monitoring
- Knowledge of statistical process control and data visualization techniques
Responsibilities
- Perform trending analysis of environmental monitoring data for viable and non-viable particulates from routine surveillance and EMPQ programs
- Author and maintain Environmental Monitoring Performance Qualification (EMPQ) reports in compliance with regulatory requirements
- Support environmental monitoring deviation investigations with data analysis and trending insights
- Participate in multifunctional project teams to support facility qualifications, investigations, and continuous improvement initiatives
- Ensure all trending activities comply with FDA, EMA, and Health Canada regulations, as well as USP, PDA, and ISPE guidance documents
- Identify trends, patterns, and outliers in environmental monitoring data and communicate findings to stakeholders
- Maintain accurate documentation and records in accordance with GMP requirements
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
