Direly Renteria

• Perform comprehensive viable and non-viable environmental monitoring within ISO 5-8 classified cleanrooms, ensuring full compliance with cGMP, FDA regulations, USP guidelines, and established Standard Operating Procedures (SOPs).
• Execute microbiological sampling of air, surfaces, personnel, and critical manufacturing environments using active air samplers, contact plates, settle plates, and swab techniques to verify cleanroom integrity and contamination control.
• Prepare, label, and manage microbiological media, reagents, and sampling materials while maintaining strict aseptic technique and preventing cross-contamination.
• Accurately document environmental monitoring activities, laboratory records, and test results in compliance with cleanroom behavior, growing procedures, and contamination control standards.
• Coordinate environmental monitoring activities with Manufacturing, Quality Assurance (QA), and Quality Control (QC) teams to ensure timely sampling, while minimizing production interruptions.
• Support the investigation of environmental monitoring excursions by assisting with data review, trend analysis, and corrective and preventive action (CAPA) activities to strengthen contamination control programs.
• Transport, incubate, inspect, and monitor microbiological samples, while maintaining environmental monitoring equipment and cleanroom sampling tools to ensure operational readiness and regulatory compliance
• Identify and communicate potential contamination risks while contributing to continuous improvement initiatives that enhance cleanroom performance, product quality, and patient safety.
• Maintain a strong commitment to data integrity, quality, safety, and regulatory compliance, while consistently meeting production schedules and laboratory deadlines in a fast-paced GMP environment.

MICROBIOLOGY LABORATORY TECHNICIAN (OCT 2022-2026)

• Conduct Performance Evaluation Testing (PET) to support laboratory quality, and microbiological testing requirements.
• Perform Growth Promotion Testing (GPT) to verify microbiological media performance prior to laboratory use.
• Prepare, label, orangish, and maintain cryovials for microbiological testing, culture storage, and laboratory sample management.
• Collect routine water samples for microbiological analysis in support of pharmaceutical manufacturing and quality control programs.
• Collaborate with Quality Assurance, Manufacturing, and Quality Control teams to support pharmaceutical production and regulatory compliance.
• Follow Good Documentation Practices (GDP), maintain accurate laboratory documentation, and ensure compliance with all quality and safety requirements.
• Operated calibrated laboratory balances, precision scales for weighing new materials, and laboratory samples while maintaining accurate documentation.
• Entered and maintained testing data in computerized laboratory systems, ensuring data integrity and compliance with Good Documentation Practices (GDP).