DANISHA RAMIREZ
Lowell,MA
Summary
Results-driven biotechnology professional with 5+ years of experience in GMP-regulated quality control and manufacturing environments. Passionate about supporting the delivery of safe, high-quality therapies through strong data integrity practices and continuous improvement. Proven ability to enhance QMS performance, support audit readiness, and collaborate cross-functionally to meet production and compliance goals. Proficient in Veeva Vault, LIMS SampleManager, ERP systems, and Microsoft Office.
Overview
3
3
years of professional experience
Work History
Quality Control Analyst I- Sample Management
Genezen Laboratories
Lexington, MA
11.2024 - Current
- Drove a 70%+ improvement in QMS performance metrics by leading the closure of overdue periodic reviews in Veeva within Q1
- Led training and qualification of a QC Lab Technician on aliquoting processes for drug product and in-process samples, achieving full sign-off in 2 months (fastest in team history)
- Drive audit readiness efforts, ensuring QC documentation, sample tracking, and processes meet GMP and regulatory expectations during inspections
- Author and manage change controls, CAPAs, and continuous improvement initiatives across QC and EHS functions
- Designed and implemented a streamlined documentation archival system, improving operational efficiency and compliance
- Act as QC Safety Officer, supporting EHS compliance, safety initiatives, and lab best practices
- Collaborate cross-functionally with Manufacturing, Quality Assurance, and external clients to coordinate sample activities, resolve discrepancies, and maintain project timelines
- Serve as QC Sample Management liaison between Manufacturing and Quality Assurance for drug product sample transfers
- Coordinate and manage domestic and international sample shipments for internal stakeholders, clients, and external testing laboratories
- Prepare and review batch disposition documentation, ensuring alignment with commercial specifications and regulatory standards
- Generate and standardize Certificates of Analysis (CoAs) to support batch release and client deliverables
- Execute assay packet reconciliation and archival, ensuring completeness, traceability, and audit readiness
- Maintain chain of custody and data integrity for manufacturing and pilot plant samples, ensuring full compliance with GMP documentation requirements
- Perform pipetting and processing of in-process, drug substance, and drug product samples to support QC analytical and bioassay testing
Downstream Manufacturing Associate I
Quanterix Corporation
Billerica, MA
10.2023 - 10.2024
- Executed routine in-process sampling of bulk solutions to support QC testing and ensure batch quality throughout manufacturing
- Authored and investigated deviation reports, identifying root causes and supporting corrective actions in alignment with GMP requirements
- Provided technical input on microbiological techniques during internal audits, supporting microbial identification and compliance efforts
- Collaborated cross-functionally with QC, Manufacturing, and Quality teams to support product validation and process verification activities
- Supported fill/finish operations and reagent formulation, ensuring accuracy, sterility, and adherence to batch records
- Performed fluorescence and absorbance-based protein analysis using TECAN plate reader to support assay development and QC testing
- Maintained accurate GMP documentation and ensured compliance with SOPs, batch records, and data integrity standards
Manufacturing Technician
Ultragenyx Pharmaceuticals
Bedford, MA
01.2023 - 10.2023
- Supported execution and review of engineering, mock, and initial GMP manufacturing runs, ensuring accurate documentation within Master Batch Records
- Authored and revised SOPs and work instructions for equipment and processes, improving clarity, compliance, and operational consistency
- Operated and maintained single-use systems including mixers, peristaltic pumps, tube sealers/welders, osmometers, and pH meters
- Collected and processed QC samples for bioburden and endotoxin testing using LIMS (LWLIMS), ensuring traceability and data integrity
- Developed and optimized documentation workflows in Veeva Vault and Excel, improving efficiency and record accuracy
Partnered with QC to perform environmental monitoring (EM), ensuring cleanroom compliance with particulate and microbial standards - Conducted airflow and occupancy studies using passive and active air sampling to determine maximum personnel limits within cleanroom airlocks
Education
Bachelor of Science - Biotechnology
Middlesex Community College
Lowell, MAAssociates in Science - Biotechnology
Middlesex Community College
Lowell, MASkills
- Corrective actions
- Quality management systems
- Customer focus
- Product Inspections
- Report creation
- Backlog management
Timeline
Quality Control Analyst I- Sample Management
Genezen Laboratories
11.2024 - Current
Downstream Manufacturing Associate I
Quanterix Corporation
10.2023 - 10.2024
Manufacturing Technician
Ultragenyx Pharmaceuticals
01.2023 - 10.2023
Bachelor of Science - Biotechnology
Middlesex Community College
Associates in Science - Biotechnology
Middlesex Community College