Glenda Betancourt
Millsboro,DE
Summary
Results-driven professional with over 20 years of experience in the biopharmaceutical and pharmaceutical industries, specializing in the production of life-saving medications within world-class manufacturing environments. Expertise in manufacturing processes and quality assurance, complemented by comprehensive training in Good Manufacturing Practices (GMP) and a strong commitment to health, safety, and security standards. Proven ability to enhance operational efficiency while ensuring compliance with industry regulations, contributing to the successful delivery of high-quality products. Dedicated to leveraging extensive knowledge to drive continuous improvement and support organizational goals.
Overview
21
21
years of professional experience
Work History
Senior Tech QC
Merck Animal Health
Millsboro, DE
07.2024 - Current
- Elisa Laboratory
- Operated and maintained laboratory equipment to ensure consistent performance and reliability.
- Collaborated with cross-functional teams to resolve technical issues swiftly and effectively.
- Trained new technicians on operational procedures and safety protocols to enhance team efficiency.
Lead Quality Assurance
Jubilant Cadista
Salisbury, MD
05.2022 - 07.2024
- Provides guidance to QA associates in their daily routine allocating and distributing work assignments and priorities.
- Assist QA Manager and Director in assessing and responding to product related complaints, investigations/deviations and in the preparation of Annual Product Reviews (APRs).
- Ensures the thoroughness and timely completion of investigations of deviations and Change Controls.
- Trains all shifts personnel on SOP’s and Work Instructions.
- Verifies batch records before issuance and maintains batch record issuance log.
- Issues batch records and associated forms to production and packaging as needed.
- Ensures compliance to Annual Cleaning Verification Program. Collects rinse samples for cleaning validation studies.
- Coordinates with other functional departments (such as MS&T/Manufacturing/QC) for process validation and test batches. Collects samples at various stages for process validation studies. Also, sample blends for testing.
- Maintains inventory records and reports of Finished Product Retain samples.
- Dispositions raw /packaging materials, labeling materials, and finished drug products in SAP system.
- Notifies production operators and supervision immediately of any problems with in process testing results.
- Communicates quality failures and other critical product concerns to QA Manager in a timely manner.
- Reviews and documents all activities on appropriate forms or in the batch record for accuracy and completion.
Lead Technician, CSA
Merck Animal Health
Millsboro, DE
12.2021 - 05.2022
- Participate daily in the TIER.
- Make improvements in the area.
- Perform QA reviews.
- Comply with the target of autoclaves, wash machines and ETC.
- Provide support in the wrapping area.
- Anticipates and solves complex production/operational problems.
- Make sure to rotate staff.
- Ensure staff complied with SOPs.
- Housekeeping in all work areas.
Coating Team lead (solid dosage)
Jubilant Cadista
Salisbury, MD
01.2020 - 12.2021
- Lead coating operations in accordance with SOP's, cGMP's, and Quality Standards.
- Supervise a team of Operators responsible for tasks in classified areas for tablet manufacturing.
- Review Operator documentation for accuracy and provide corrections and training as needed.
- Take part in investigations and implement approved corrective/preventative actions (CAPA) for processes in classified areas and execute Change Controls.
Quality Assurance/Quality Control
Jubilant Cadista
Salisbury, MD
01.2016 - 01.2020
- Performing batch records review.
- Monitoring and performing raw material samplings.
- Collecting rinse and swab samples.
- Assist QA Manager and Director in assessing and responding to product related complaints, investigations/deviations and in the preparation of Annual Product Reviews (APRs).
- Executing rooms and equipment's release for manufacturing process.
- Handling recalls and returned goods.
- Following Good Manufacturing Practices and Standard Operating Procedures (SOPs)
- Adhering to all safety and company policies.
Quality Assurances
Mountaire Farms
Selbyville, DE
01.2015 - 01.2016
- Responsible for ensuring products meet company requirements.
- Monitor and record product temperature.
- Enter data into Citrix system.
- Execute water sampling.
- Conduct PH tests.
- Execute, gloved fingertip testing.
- Follow Good Manufacturing Practices and Standard Operating Procedures (SOPs)
- Adhere to safety and company policies.
Microbiologist Technician
McNeil Pharmaceuticals
Las Piedras, PR
01.2013 - 01.2014
- Responsible for evaluating new methods to improve laboratory processes.
- Documents and verifies data.
- Creates, executes, and reviews validation protocols for suitability, methods, and equipment.
- Execute water sampling and analysis (Purified Water, Potable).
- Execute Environmental sampling and analysis.
- Ensures compliance with Good Manufacturing Practices and Standard Operating Procedures (SOPs)
- Adheres to all safety and company policies.
Microbiologist Technician
Wyeth/ Pfizer Pharmaceuticals
Guayama, PR
01.2007 - 01.2013
- Responsible for evaluating new methods to improve laboratory processes.
- Documents and verifies data.
- Creates, executes, and reviews validation protocols for suitability, methods, and equipment.
- Execute water sampling and analysis (Purified Water, Potable).
- Performed Raw Materials analysis.
Microbiologist Technician
Amgen Pharmaceuticals
Juncos, PR
01.2005 - 01.2007
- Responsible for evaluating new methods to improve laboratory processes.
- Documents and verifies data.
- Creates, executes, and reviews validation protocols for suitability, methods, and equipment.
- Execute water sampling and analysis (Purified Water, Potable and Steam water).
- Performs validation plans.
- Supports and prepares protocols for building start-up.
- Monitors manufacturing at a new facility.
- Execute, gloved fingertip testing.
- Collects Environmental samples.
- Ensures compliance with Good Manufacturing Practices and Standard Operating Procedures (SOPs)
- Adheres to all safety and company policies.
Education
Bachelor Degree - Microbiology
Inter Americana of Puerto Rico
Mercedita Ponce, PR01-2005
Skills
- Team lead, Sampling swabbing, pH meter (calibration and use), conductivity meter (calibration and use), QA, Biotechnology manufacturing process, manufacturing process, good documentation practices cGMP’s, Train of trainer), Batch records review and CAPA
- Knowledge in Microsoft Office: MS Word, Power Point, Excel Batch Analytics, EBR electronic batch records, Track Wise system, Reliance and SAP
Languages
Spanish
Timeline
Senior Tech QC
Merck Animal Health
07.2024 - Current
Lead Quality Assurance
Jubilant Cadista
05.2022 - 07.2024
Lead Technician, CSA
Merck Animal Health
12.2021 - 05.2022
Coating Team lead (solid dosage)
Jubilant Cadista
01.2020 - 12.2021
Quality Assurance/Quality Control
Jubilant Cadista
01.2016 - 01.2020
Quality Assurances
Mountaire Farms
01.2015 - 01.2016
Microbiologist Technician
McNeil Pharmaceuticals
01.2013 - 01.2014
Microbiologist Technician
Wyeth/ Pfizer Pharmaceuticals
01.2007 - 01.2013
Microbiologist Technician
Amgen Pharmaceuticals
01.2005 - 01.2007
Bachelor Degree - Microbiology
Inter Americana of Puerto Rico