Merlyn Amparo Bautista
Lawrence
Summary
Strong attention to detail as well as excellent oral, written communication, and presentation skills, with the ability to communicate confidently. Technical knowledge of using quality management systems under both quality assurance and quality control settings. Experienced working with Microsoft Office Suite. Detail-oriented team player with strong organizational skills, a willingness to take on added responsibilities to meet team goals, and the ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
4
4
years of professional experience
Work History
Quality Assurance Specialist
Atrium Staffing (Client: Vertex Pharmaceuticals)
09.2024 - Current
- Provide QA review of the GMP data in support of release of commercial product as required
- Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function
- Represent QA Analytical on cross-functional teams as an experienced Quality technical resource as needed
- Support quality oversite of root-cause analysis and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified
- Support change control assessment, implementation, and closure as needed
- Conduct GxP document review
- Draft and enforce Quality Agreements between CMOs/Suppliers and Vertex, as needed
- Identify and facilitate continuous improvement efforts
- Support generations and maintenance of Quality Metrics to support process improvement activities as necessary
- Identify and communicate risks and assist with risk mitigation plans as necessary
Quality Assurance Coordinator
Atrium Staffing (Client: Vertex Pharmaceuticals)
09.2023 - 09.2024
- Participated in cross-functional teams as a Quality Technical resource
- Enforced Quality Agreements between CMOs/Suppliers and Vertex, as needed
- Supported quality event investigations /deviations and reviews corrective action plans for adequacy and
compliance - Ensured appropriate CAPA actions are identified and addressed
- Maintained Quality Metrics to support on time release deliverables
- Conducted GMP document review
QC Scientist
Thermo Fisher
11.2022 - 09.2023
- Performed routine environmental monitoring and utility sampling
- Performed routine microbiology assays
- Inventory and restocking of QC lab
- Reviewed data and enter results into LIMS system
- Sample shipment to external testing lab
- Opened alert and action level quality records onto Trackwise
- Revised SOPs and work instructions
- OOS's and Deviations
- Reviewed relevant laboratory documents
Medical Assembler/Quality Control
EMD Millipore Sigma
08.2020 - 10.2022
- Tested equipments and other related supplies
- Measured instruments to ensure conformance to the specifications
- Took corrective actions where possible
- Inspected products to the established quality standards and reviewed batch records
- Understood and followed all written documents including standard operating procedures (SOP's), forms, test Methods, and test Specifications
- Trained new employees on the process/workflow
Education
Bachelor of Science - Biotechnology
Northeastern University
Boston, MA08.2022
Associate of Science - Science
Middlesex Community College
Lowell, MA12.2020
Skills
- Review of GxP Documents
- Routine GxP Laboratory Assays
- Technical Writing
- Quality Event Management (CAPAs, Deviations, OOS/OOT)
- Process Improvements
- MS Suite
- Trackwise, Veeva, LIMS, Documentum D2
- Quality Metrics
Languages
Spanish
Native or Bilingual
Timeline
Quality Assurance Specialist
Atrium Staffing (Client: Vertex Pharmaceuticals)
09.2024 - Current
Quality Assurance Coordinator
Atrium Staffing (Client: Vertex Pharmaceuticals)
09.2023 - 09.2024
QC Scientist
Thermo Fisher
11.2022 - 09.2023
Medical Assembler/Quality Control
EMD Millipore Sigma
08.2020 - 10.2022
Bachelor of Science - Biotechnology
Northeastern University
Associate of Science - Science
Middlesex Community College
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