Julieta Silva

Manville

Summary

Highly skilled QC Microbiologist with background in performing microbial tests, quality control audits, and environmental monitoring. Strengths include maintaining accurate records, interpreting complex data, and complying with regulatory guidelines. Notable contributions include successful implementation of improved testing methods and procedures that enhanced efficiency and accuracy in previous role.

Overview

years of professional experience

Work History

QC Microbiologist Tech

Ferring Pharmaceuticals

Parsippany

01.2022 - Current

Environmental Monitoring performs tests for monitoring environmental conditions throughout the facility and maintains all documentation for traceability.
Performs environmental sampling of the manufacturing areas, which includes collecting air, surface and water and gas samples in support of facility environmental procedures in accordance with cGMP and corporate policies.
Support production operations by performing environmental monitoring of batching processes:
Maintain grade A, B, C and D production areas by performing routine environmental monitoring, water and gas sampling at established frequencies
Use LIMS software to create labels, collect and submit QC samples to the labs
Operate air samplers to perform viable and non-viable air monitoring.
Operate production equipment as needed to sample water and gas utilities.
Basic laboratory tasks as well as other responsibilities, as assigned.
Process and identify microorganisms (MID’s) completed forms and summit for review.
Perform TPC, Bulk and Coliform Test.
Perform binder and documentation review.
Incubate, read and verify plates.
LIMs training and review SOPs.
Gown in clean room and aseptic technique.

Production Technician

Allergan

Branch-burg

04.2020 - 05.2021

Equipment Operation and Maintenance:Setting up and maintaining production equipment, troubleshooting issues, and ensuring optimal performance, often including using SOPs.
Process Execution:Executing production processes according to established procedures, including filling, packaging, and other manufacturing steps.
Quality Control:Performing quality checks, sampling, and testing of raw materials, in-process materials, and finished products.
Documentation:Maintaining accurate records of production activities, including batch production records, logbooks, and yield calculations.
GMP Compliance:Adhering to Good Manufacturing Practices (GMP) guidelines and procedures throughout the production process.
Inventory Management:Maintaining inventory levels of raw materials, components, and finished products.
Problem Solving:Identifying and resolving production issues, collaborating with engineers or supervisors when necessary.
Safety:Following safety protocols and procedures to ensure a safe work environment.Example

Environmental Monitoring Tech

PharMEDium

Dayton

06.2014 - 04.2020

Perform Environmental Monitoring (EM) in an aseptic environment (batch, routine, gowning monitoring, and utility testing).
Performs Daily, Weekly, Monthly, and Quarterly EM.
Performs viable air, non-viable particle counts, and contact surface testing.
Completes all necessary documentation on GMP documents in real-time.
Responsible for the accurate recording, review, and storage of laboratory data.
Implement Data Integrity for reliable, accurate, and complete laboratory data.
Assist with the setup and daily running of the EM laboratory.
Participate in EM lab operations on a daily, weekly, monthly, and quarterly schedule.
Incubate and enumerate organisms on cultured media.
Prepare for shipping to a contract lab, Out-of-Specification (OOS) media plates, and finished product.
Ship QC equipment for calibration as required per established policies and procedures.
Provide EM support including review, tracking of EM of Microbiology results in support of product release. In conjunction with Quality Assurance, ensure timely completion and data review of routine and batch-related microbiological data.
Assist with facility qualification and validation as required.
Ensure proper equipment function, calibration, maintenance, and troubleshooting of laboratory equipment.
Assist with the initiation of investigations/deviations and the determination of root causes analysis.
Participate in hazardous waste training. Transfer of hazardous waste between lab and trash accumulation area/storage.
Seeks continuous improvement within EM related activities.
Initiates the review/revision of EM related Standard Operating Procedures (SOPs).
Supports the QC Manager in projects relating to EM technician tasks.
Follow best practices, quality trends, and regulatory requirements.
Follows Standard Operating Procedures designed to ensure quality in EM tasks, consistent with established standards in Wells.

Education

Pharmacy Technician

Middlesex County College

Edison, NJ

06-2018

Associate of Science - Biology

Raritan Valley Community College

Somerville, NJ

Skills

Knowledge of microbiology: Understanding microorganisms, their behavior, and growth conditions
Laboratory techniques: Proficiency in aseptic techniques, culturing, staining, and other common lab procedures
Equipment operation: Experience with microscopes, centrifuges, incubators, and other lab equipmentQuality control: Understanding and applying quality control measures in the lab

Attention to detail: Accuracy in recording data, following protocols, and ensuring results are reliable
Communication: Ability to communicate effectively with colleagues, supervisors, and other healthcare professionals
Problem-solving: Ability to identify and resolve issues in the lab, troubleshoot equipment malfunctions, and adapt to changing situations
Teamwork: Working collaboratively with other lab personnel and other departmentsOrganizational skills: Ability to manage time effectively, prioritize tasks, and maintain a clean and organized workspace

Timeline