Yaliza Lacen Allende
Bloomington,USA
Summary
Quality Assurance professional with 6 years of experience in pharmaceutical manufacturing, focusing on regulatory compliance and Quality Control. Established effective CAPA management systems and good documentation practices, resulting in enhanced compliance with GXP standards. Demonstrated strong analytical and problem-solving skills, contributing to optimized operational efficiency.
Overview
7
7
years of professional experience
Work History
QC Microbiology Tech
Baxter/Simtra Pharmaceutical
Bloomington, IN
09.2023 - 04.2025
- Monitored machines that automatically measure, sort and inspect products.
- Checked arrived materials to ensure that matched purchase orders, submitting discrepancy reports as necessary.
- Collected and selected samples for testing and for use as models.
- Notified supervisors and other personnel of production problems.
- Collected data and developed and utilized appropriate metrics for facilitating case reviews and root cause analysis.
- Ensured compliance with industry standards through rigorous testing methods.
- Analyzed product requirements and developed test scenarios to identify potential issues.
- Generated daily reports outlining overall status of current projects under test at any given time.
- Collaborated with developers in debugging errors found during testing process.
- Documented test cases for functional, regression, stress, performance, localization, usability tests.
Quality Assurance Representative
Catalent Pharmaceutical
Bloomington, IN
01.2022 - 04.2023
- Currently providing support to the quality function by overseeing GMP activities, documentation and reports.
- Responsibilities include participating in and supporting internal, client, regulatory and/or vendor audits to ensure internal and external operations.
- Documentation review of executed assigned quality tasks.
- TrackWise deviation reports, change controls & EDMS documentation review & approval.
- Review Cleanroom aseptic techniques requirements and manufacturing regulations in the batch records.
- Certify pre- and post- review of batch production records.
- During operation, ensure all work is performed in compliance with Standard Operating Practice (SOP), Good Manufacturing Practice (GMP), and regulatory requirements.
- Review and approve Change Controls and Deviation investigations.
- Assess the impact of change controls and events on the product and regulatory requirements.
- Qualify all personnel meet all the requirements to perform the procedures.
- Review, approve, and release critical raw materials for use in production and the Quality Control laboratories according to established specifications and escalate any discrepancies immediately.
- Certified documentation is compliant and consistent with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Support QA Operations with FDA interactions.
- Follow up on Clients requests for change disposition with quality and data integrity.
Sr. Manufacturing Associate Packaging
Catalent Pharmaceutical
Bloomington, IN
01.2021 - 01.2022
- Performed Routine Monitoring duties while also verifying Batch Records & Logbooks.
- I also verified lot documentation related to lot count, labeling inspections and reject classification.
- I performed line clearance and used the JD Edwards process to transfer incoming materials & outgoing finished product.
- I am familiar with processes in a laboratory and aseptic environment due to my nursing background.
- Some examples are use of Autoclaves and laboratory equipment, performing formulation duties, chemical dispensing/inventory, recording medical data and providing reports based on patient interviews, performing sampling activities based on local Standard Operating Procedures.
Quality Inspector
Cook Medical
Bloomington, IN
09.2018 - 01.2021
- Bore Scoping Quality Control Inspector.
- Medical Device Assembler.
- Packaging Operator/Manufacturing Associate.
- Various responsibilities depending on departmental workload needs.
- Ex. Printing labels, assembling devices and performing inspections.
Education
BSN - Nursing
National University College of Business & Technology
Rio Grande, P.R.07.2018
RN - Nursing
National University College of Business & Technology
Rio Grande, P.R.07.2011
LPN Nurse Practice - Certificate of Nursing
Metro College
Rio Piedras, P.R.05.1998
Criminology - Associate Degree of Social Science
University of Puerto Rico
Carolina, P.R.07.1990
Skills
- Attention to detail
- Aseptic techniques
- Performance monitoring
- Problem-solving
- Quality control
- GXP and FDA regulations
- TrackWise and JDE
- Maximo and Lim's
- CAPA management
- Laboratory equipment handling
- Formulation processes
- Inventory management
- Finished product labeling
- Pharmaceutical packaging
- Data collection and analysis
- Root cause analysis
- Sterilization techniques
- Laboratory safety protocols
- Regulatory compliance
- Laboratory record keeping
- Test case development
- Manual testing expertise
- Documentation and reporting
- Critical thinking skills
- Requirements analysis
- Software development methodologies
- Test strategy formulation
- Functional testing proficiency
- Finished product inspection techniques
- Quality system implementation strategies
- Technical documentation skills
- Decision-making processes
References
Available upon request.
Competency Highlights
- Experience 6 years’ in pharmaceutical manufacturing.
- Proficient in critical thinking and problem solving with demonstrated ability to carry out tasks independently.
- Technically strong, detail-oriented team player with leadership and mentoring skills.
- Excellent communicator with fluency in English and Spanish.
- Familiar with GXP and FDA regulations.
- Advanced user level skills in software and apps used in pharmaceutical industry (TrackWise, JDE, Maximo, Lim’s, Outlook, CAPA).
Languages
Spanish
Professional
Timeline
QC Microbiology Tech
Baxter/Simtra Pharmaceutical
09.2023 - 04.2025
Quality Assurance Representative
Catalent Pharmaceutical
01.2022 - 04.2023
Sr. Manufacturing Associate Packaging
Catalent Pharmaceutical
01.2021 - 01.2022
Quality Inspector
Cook Medical
09.2018 - 01.2021
BSN - Nursing
National University College of Business & Technology
RN - Nursing
National University College of Business & Technology
LPN Nurse Practice - Certificate of Nursing
Metro College
Criminology - Associate Degree of Social Science
University of Puerto Rico
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