Quality Assurance Lead with 6 years of experience in Pharmaceutical’s. Knowledge the Standard Operating Procedures (SOP) and the Good Manufacturing Practices cGMPs. Proven experience working directly in QA and QC functions in the Pharmaceutical’s procedure with a strong understanding of general practices. Lead team to insure everyone is following the GMPs. Supervised and trained operators according to SOP specifications and procedures. Corrected documents and procedures according the procedures to follow. Controlled production and kitting quality standards. Supervised quality control of repackaging pharmaceuticals products, ensuring adherence to all FDA regulations. Experienced using various instruments to perform inspections of product in all different areas accordance to standard operating procedures and FDA requirement.
Hi, I’m
Yaquelyn Quintanilla
Bay Shore,US
Summary
Overview
6
years of professional experience
Work History
Gemini IncCommack, NY
Quality Assurance Lead
11.2018 - Current
Job overview
- Performed annual audits and random quality inspections of plant facilities.
- Implemented safety training for new hires and re-training for current employees.
- Identified quality problems and recommended solutions.
- Received and inspected raw materials.
- Identified and troubleshot equipment problems.
- Trained employees in proper equipment use and product testing procedures.
- Trained and developed doing checking tablets the weight, thickness and harness as per every product, same as the capsulation department if is running ok with any issues as broken, dented, telescoping or color variation capsules, etc
- Experienced closing batch record from all departments manufacturing and packaging.
- Perform AQL in packaging lines every half hour and capsulation department as well.
- Performance Qualification of tablet press
- Perform room and equipment Cleaning checks and sanitizing following written procedures.
- Analyzed and processed micro, manufacturing and packaging samples on every step of the product.
- Reviewed quality trends to prevent or reduce defects, determined problem causes and initiated actions for correction.
- Performance MET Pharmaceuticals in bulk inspection or packaging line’s.
- knowledge in receiving components and products.
- Experience in Inspection department.
- Provided guidance on best practices related to testing protocols, sampling plans, statistical analysis.
- Monitored supplier performance against established standards for material inputs used in production processes.
- Provided training on quality assurance principles and techniques to personnel in all departments.
- Assisted in preparing documents needed for certification by external bodies such as FDA regulations.
Good Samaritan Nursing HomeSayville, NY
Nursing Assistant
01.2019 - 06.2019
Job overview
- Engaged with patient family and friends to provide courteous visit experience.
- Looked for physical, emotional and symptomatic changes in patient condition and obtained necessary care for medical concerns.
- Documented nursing assessments, treatments and follow-up care to maintain patient safety and optimize workflow.
- Assessed vitals and noted medical information to report changes to nursing staff and physicians.
- Promoted patient satisfaction by assisting with bathing, dressing and exercising.
- CPR certificate
- Performed basic nursing skills such as changing wound dressings.
- Ensured that all equipment was functioning properly prior to use.
- Observed patients' conditions regularly for any physical or mental changes and reported findings to the appropriate personnel promptly.
Education
Access Careers - IslandiaIslandia, NY
Nursing Assistant
06-2024
University Overview
Eastern Long Island Academy Applied TechnologySayville, NY
Nursing Assistant
06.2019
University Overview
Brentwood High SchoolBrentwood, NY
High School Diploma
06.2019
University Overview
Skills
- Fluent in both English and Spanish
- Safety procedures
- Independent
- Ability to work with team player or an individual starter
- Responsible
- Self-reliant in identifying solutions to bring high-reliability solutions to a successful conclusion
- cGMP
- Quality Inspection
- Quality Control QC/QA
- FDA regulations
- Manufacturing and Packaging
- Adaptability and Flexibility
- Quality SOPs Development
- Independent Decision Making
Timeline
Nursing Assistant
Good Samaritan Nursing Home
01.2019 - 06.2019
Quality Assurance Lead
Gemini Inc
11.2018 - Current
Access Careers - Islandia
Nursing Assistant
Eastern Long Island Academy Applied Technology
Nursing Assistant
Brentwood High School
High School Diploma
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