Idalis J. Morales
Gurabo ,PR
Summary
Proven leader in biomanufacturing, adept at protein purification and fostering teamwork, significantly enhanced production efficiency at Amgen Manufacturing Limited. Skilled in microbiological testing and promoting safety standards compliance, I excel in optimizing processes and driving quality improvements. My background includes comprehensive experience in regulatory and manufacturing process audits, underscoring a commitment to excellence and innovation in the field.
Overview
3
3
years of professional experience
Work History
Manufacturing Associate
Amgen Manufacturing Limited | MSSS, Inc.
Juncos
01.2022 - Current
- Manufacturing in the fermentation and purification process of the E.coli bacteria to obtain the recombinant protein of Neupogen (Filgrastim), Neulasta (Pegfilgrastim), Nplate (Romiplostin), and Krystexxa (Peglotycase) through the use of unit operations such as Ultrafiltration/Diafiltration, Chromathrographs, Centrifuges, Acid Precipitation, Solubilization, Oxidation, Clarification, and Protein Titration.
- Preparation of small and large buffers and media.
- Attending and maintaining area needs in accordance with Good Manufacturing Practice (cGMP), Standard Operating Procedure (SOPs), Good Laboratory Practices (cGLP), and other regulations company policies and pharmaceutical standards.
- Follow safety protocols and utilized OSHA-approved PPE to foster safe working environment.
- Recovery, Dilution and prepare Product to Bulk Filtration activities.
- Preparation activities such as drainage, cleaning in place (CIP), pressure test (PT), and steaming in place (SIP).
- Experience in electronic systems such as: documentation platforms (CDOCS), LIMS and electronic lot registration (MES).
- Sampling with dilution of EIA, Novaseptum , TOC, and analytical tests for pH, conductivity, LAL, and UV test.
- Management of Online-SIMCA, RT-Report, Symphony, Process Control System (PCS), and Forms on Manual Input and Electronic as well.
- Collaborated with other departments to optimize production workflows.
- Trained new production staff members on safe and efficient production procedures and proper machine operations.
- Assisted in new product development by contributing ideas during brainstorming sessions and testing prototypes for functionality and durability.
- Supported the implementation of new procedures or systems within the facility, adapting quickly to changes while maintaining high-quality output levels consistently.
- Ensured workplace safety by following all company guidelines, participating in regular safety audits, and promptly addressing hazards as they arose.
- Participated in regular team meetings to discuss progress, address challenges, and align on strategies for achieving production goals.
Quality Assurance Technician
Ethicon, LLC J&J Medical Devices | Kelly Services
San Lorenzo
06.2021 - 01.2022
- Clearance of the packaging lines, avoiding the combination of different batches.
- Performed thorough inspections of incoming materials and outgoing products.
- Contributed to continuous improvement initiatives by actively participating in regular team meetings and sharing insights about potential areas of improvement.
- Inspected finished products for overall quality and adherence to packaging lines specifications.
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Ensured timely resolution of non-conformance issues by effectively communicating findings to relevant departments and recommending corrective actions.
Assembler
Medtronic | CTS Inc.
Juncos
02.2021 - 06.2021
- Assembly of the "Guardian Sensor" product. Sensor used to monitor glucose.
- Increased production efficiency by assembling components quickly and accurately.
- Collaborated effectively with team members to meet production targets consistently.
- Demonstrated flexibility in adapting to various types of assemblies, allowing for seamless transition between different projects as needed.
- Maintained high-quality standards with thorough inspections of assembled parts.
- Created reports to document and provide information regarding production progress and developments.
- Assembled parts correctly according to specifications, reducing quality issues.
- Recognized and reported defective material and equipment to shift supervisor.
- Inspected completed products to encourage quality and adherence to company standards.
Education
Bachelor of Science - Microbiology
University of Puerto Rico
Humacao, PR05.2021
Skills
- Production Scheduling
- Attention to Detail
- Teamwork and Communication
- Computer Skills
- Product Assembly
- Materials Inspection
- Visual Inspection
- Quality assurance standards
- Production Documentation
- Quality Inspection
- Safety Standards Compliance
- Flexible Schedule
- English Fluency
- Problem-Solving
- Microbiological testing
- Sterilization techniques
- Good laboratory practices
- Fermentation Processes
- Leadership skills
- Protein Purification
- Laboratory techniques
- Sample Collection
- Microbiology Techniques
- Regulatory Audits
- Manufacturing Process Audits
Languages
Spanish
Native or Bilingual
English
Professional Working
Timeline
Manufacturing Associate
Amgen Manufacturing Limited | MSSS, Inc.
01.2022 - Current
Quality Assurance Technician
Ethicon, LLC J&J Medical Devices | Kelly Services
06.2021 - 01.2022
Assembler
Medtronic | CTS Inc.
02.2021 - 06.2021
Bachelor of Science - Microbiology
University of Puerto Rico