Genaro Rubina

ad2ft7@r.postjobfree.com • 732-***-****

Middlesex, NJ, US

Highly analytical and driven professional with a strong background in the Biopharmaceutical & Medical Device industries. Knowledge of Python programming, DBMS, MySQL, ML, Artificial Intelligence, Data Visualization using Tableau/Power BI, Matplotlib and Capstone Project. Cleaned and preprocessed raw data, ensuring data quality accuracy. Demonstrated capacity for training employees in testing/assembly of experimental processes. Adept at collaborating with coworkers in an organized team environment, working alone with minimal supervision, and maintaining a positive attitude to meet business needs. Possessed in-depth knowledge of FDA, DEA, cGMP, GLP, OSHA, EHS, SOP, Parts 210 & 211, and Federal regulations.

Professional Experience

Ethicon - Med-Tech, Raritan, NJ 08/2022 – Present

Sample Management – Global Product Stability, R & D - Biosurgery

Responsible for the efficient and effective functioning of the Stability Studies Sample Lifecycle Management Program. Responsible for managing the accurate receipt and storage of incoming sample shipments to the site and the accurate shipping of samples to various other labs/sites. Oversee monitoring of stability storage conditions, Inventory stability samples, and status of laboratory test results ensuring stability programs’ progress according to the established protocols and Laboratory Information Management System (LIMS).

Sanofi North America Quality – US PQC, Bridgewater, NJ 02/2022 – 07/2022

Associate Analyst - Product Technical Complaint

Responsible for handling Product Technical Complaints and Field Alerts for medical devices, Biopharmaceutical products, biologics, and combination products. Communication with consumers, business partners, and vendors for information gathering and processing. Creating write-ups and making cases on a daily basis. Prioritizes complaints for data entry and processing into the department PTC database. Interact with both internal and external manufacturing sites regarding technical complaints and their associated investigations. Handling software such as SIEBEL, COGNOS, and COMET for business care processing. Identifies and reports adverse events within one business day to pharmacovigilance.

Catalent Pharma Solutions, Somerset, NJ 05/2021 – 02/2022

Pharmaceutical Development Technician

Utilized advanced technical skills to assist with early-stage Development and Clinical Batch. Analyzed samples to ensure quality by performing in-process sampling and testing. Resolved problems with the equipment while overseeing the set-up and daily operation. Initiated process improvement and successfully executed. Identified potential problems regarding safety and proactively corrected them by employing strong problem-solving and critical thinking proficiency.

Cosette Pharmaceuticals, South Plainfield, NJ 12/2017 – 05/2021

Quality Assurance / Control – Stability Coordinator II

Oversaw various facets involved in receiving, labeling, Inventory, and storing stability samples in designated stability chambers. Updated for the efficient and effective functioning of the Quality Control Stability Studies sample lifecycle management program Scien-Tek database. Delivered assistance in creating and maintaining controlled documents and records upon request. Offered continuous support to supervisor in crafting accurate and on-time annual product review reports of stability raw data for regression analysis.

G&W LABORATORIES, INC., South Plainfield, NJ 02/2012 – 11/2017

R&D / Product Development - Technician

Maintained written record of instruments, equipment used, and cleaning included in individual equipment. Introduced Quotation/purchase orders and utilized the ERP system to order laboratory reagents, chemicals, and instruments. Directed end-to-end operations involved in calibrating and verifying test instruments and equipment to minimize any measurement uncertainty by ensuring the accuracy of test equipment. Offered ongoing support to formulation scientists and process engineers in producing development as well as pilot batches for NDA & ANDA submission.

G&W LABORATORIES, INC., South Plainfield, NJ 06/1998 – 01/2012

Quality Control – Laboratory Technician

Examined incoming raw materials, in-process, and finished product samples and transferred them to the quality control laboratory for further analysis. Managed inventory level and introduced purchase orders to restock laboratory chemicals and reagents in accordance with USP reference standards. Steered various activities encompassing labeling raw material status from quarantine to release. Ensured storage of retained finished products in an appropriate manner for accountability, annual evaluation, and retrieval.

Education

Post Graduate Program Master in Data Science College De Paris Ascencia Business

Bachelor of Commerce in Accounting INSTITUTO SUPERIOR TECHNOLOGICO Peru