Diana Perez Valle
Gaithersburg,MD
Summary
Dynamic pharmaceutical professional with extensive experience at Sanaria, excelling in GMP compliance and quality assurance. Proven track record in training personnel and developing SOPs, ensuring product integrity through meticulous visual inspections. Skilled in cold chain management and effective communication, driving operational excellence in biopharmaceutical manufacturing.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Pharmaceutical Operator
Sanaria
Gaithersburg, MD
06.2024 - Current
- Executed visual inspection program at clinical trial sites by pharmaceutical operators.
- Guided and trained new personnel on visual inspection operation techniques.
- Developed and maintained SOP-compliant training documentation for GMP processes.
- Ensured employee training documentation met GMP and regulatory compliance standards.
Lead Visual Inspector
Sanaria
Rockville, MD
08.2021 - Current
- Created and implemented an inspection program for empty container for parenteral products
- Trained new inspectors on proper inspection techniques and procedures.
- Inspected products for defects, quality, and accuracy of product specifications.
- Participated in and executed POD studies as part of the visual inspection qualification process per FDA guidance and USP <790>/<1790>.
- Authored SOPs, visual inspection qualification protocols, and contributed to regulatory audit responses related to product integrity and inspection effectiveness.
- Supported development of defect libraries and training sets using statistically sound POD methodology
- Communicated effectively with management regarding any discrepancies found during the inspection process.
- Created and implemented an inspection program for finished products
Quality Control
Sanaria
Rockville, MD
04.2020 - Current
- Conducted tests on product samples and recorded results.
- Performed visual inspections of finished products.
- Trained employees in proper equipment use and product testing procedures.
- Made and stocked reagents for ensuring the accuracy and consistency of the reagents.
Research Associate II
Sanaria
Rockville, MD
04.2020 - Current
- Trained in shipping biological and investigational products to clinical trial sites.
- Ensured stability of vaccines through effective cryopreservation of biological materials.
- Retrieved investigational materials from LNVP storage cryotanks efficiently.
- Compiled and organized research data to generate detailed reports and graphs.
- Maintained organized records and inventory of equipment and materials.
- Reviewed and created SOPs and associated forms for operational consistency.
- Executed shipping of investigational products using various couriers, including FedEx, World Courier, BioCair, Cryoport, and DHL.
- Monitored performance levels of equipment and initiated maintenance requests as necessary.
- Ensured proper cold chain handling of biological samples, maintaining temperature integrity from receipt to use.
- Monitored and documented temperature conditions using data loggers, thermocouples, and real-time tracking systems.
- Maintained integrity of cold chain systems for temperature-sensitive biological products (2–8°C, -150°C, or -80°C) during storage, handling, and shipment.
Vaccine Extraction Specialist (part-time)
Sanaria Inc.
Rockville, MD
08.2018 - Current
- Trained as a clinical manufacturing vaccine extraction specialist - skilled in the extraction of the malaria vaccine from aseptic mosquitos in a clean manufacturing setting.
- Gowning-qualified to work in ISO 7 cleanroom environments; follow aseptic techniques and cleanroom protocols for sterile product handling under GMP regulations.
Office Associate
Perez Landscaping & Stone Works Inc.
Gaithersburg, Maryland
09.2012 - 03.2020
- Assisted in writing and building contracts, sent weekly payrolls, scheduled meetings, tended to email & phone calls from clientele.
- Managed and anticipated clerical needs of company employees, including copying, faxing and file management.
- Filed and retrieved records to support business needs and boost team productivity
Education
Bachelor of Science - Biology
University of Maryland
College Park, MD01.2019
Associate of Science - Life Sciences
Montgomery College
Rockville, MD01.2016
Skills
- CMF Gowning certified
- PPE trained
- CGMP qualified
- CGDP qualified
- Quality assurance standards proficient
- Inventory assessments and reconciliation proficient
- Trained in Biological Safety Cabinet usage and cleaning (Laminar and Biosafety cabinets)
- Aseptic Technique
- Probability of Detection (POD) Study Execution & Analysis
- USP , , EU Annex 1 Compliance
- Deviation management (Novatek)
- Proficient in microscopy (microdissection, compound, and fluorescence)
- Able to analyze, understand, and present research articles pertaining to current studies
- Proficient in Microsoft Offices (Word, Excel, PowerPoint, Outlook etc)
- Knowledgeable in the creation/review process of SOPs
- Knowledgeable in shipping domestically and internationally
- Trained clinical trial personal on documents, forms, and equipment
- CCIT training
- Finished product testing
- Batch record documentation
- Visual inspection
- SOP development
- Employee training
- GMP compliance
- Cold chain management
- Biopharmaceutical manufacturing
- De
- Stability testing
- Hazardous materials handling
- Sterilization methods (autoclave)
- Dangerous Goods training (Saf-T-Pak)
Certification
- SAF-T-PAK Shipping Infectious Substances & Related Materials APR2020-APR2022
- CITI Training MAY2020
- Good clinical practice and FDA focused good clinical practice course
Languages
English
Professional
Spanish
Professional
Websites
Timeline
Pharmaceutical Operator
Sanaria
06.2024 - Current
Lead Visual Inspector
Sanaria
08.2021 - Current
Quality Control
Sanaria
04.2020 - Current
Research Associate II
Sanaria
04.2020 - Current
Vaccine Extraction Specialist (part-time)
Sanaria Inc.
08.2018 - Current
Office Associate
Perez Landscaping & Stone Works Inc.
09.2012 - 03.2020
Bachelor of Science - Biology
University of Maryland
Associate of Science - Life Sciences
Montgomery College
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