Andrea Ramos-Rivera
Relocating To Boston, MA - Currently In San Antonio
Summary
Detail-oriented Quality Specialist experienced in FDA-regulated and AATB-accredited tissue manufacturing. Expertise in batch record review, non-conformance identification, and post-processing quality testing. Committed to ensuring compliance with safety and quality standards for patient use while training personnel and driving continuous quality improvement.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Quality Control Specialist
Tiger BioSciences-RegenTX
San Antonio
09.2024 - Current
- Execute thorough batch record review to verify data integrity, procedural compliance, and conformance with validated process parameters and expected quality outcomes.
- Detect, investigate, and document quality control non-conformances to ensure compliance with established specifications and regulatory standards.
- Initiate and support investigations for quality events.
- Execute environmental monitoring for cleanrooms and equipment.
- Follow procedures according to FDA, AATB, other applicable regulations.
- Conducted post-irradiation quality testing on human tissue products, ensuring release for commercial distribution only after meeting established acceptance criteria.
- Supported audits by preparing necessary documentation and reports.
- Performed detailed inspections of incoming materials, ensuring they met the required standards.
- Collaborated with production teams to ensure compliance with standards.
- Train and onboard new employees on quality procedures and operational standards.
Phlebotomist/Donor Care Specialist
South Texas Blood & Tissue
San Antonio
03.2023 - 09.2024
- Collected blood samples using sterile techniques and proper equipment.
- Maintained accurate records of donor information and sample collection details to ensure compliance and traceability.
- Adhered to HIPAA guidelines regarding patient privacy.
- Adhered to FDA protocols and standard operating procedures while conducting blood collection.
- Performed venipuncture by locating veins suitable for puncture to draw blood using sterilized needles, vials and other equipment. Identified best veins for donation and blood draws, avoiding unnecessary second draws.
- Verified patient information prior to specimen collection and conducted extensive screening of donors that include vital signs and medical questioning
- Assisted in the training of new phlebotomists.
- Monitored donors for unusual reactions or events, responding promptly according to established guidelines to ensure donor well-being.
Lab Assistant
University of the Incarnate Word
San Antonio
01.2022 - 07.2022
- Conducted cell research at an undergraduate level.
- Supported faculty and students during laboratory sessions and experiments.
- Assisted in preparing lab materials and equipment for experiments.
- Documented experimental procedures and results accurately in lab notebooks.
- Recorded and reported test results accurately according to established procedures.
- Collaborated with team members to ensure a safe working environment.
Education
Bachelor's Degree in Biology
University of The Incarnate Word
San Antonio, TX05-2022
Skills
- Batch record review of HCT/P production records along with allografts produced
- Environmental monitoring
- Non-conformance reporting
- Laboratory techniques
- cGMP and CGTP regulations
- ISO 6 cleanroom experience
- Specimen collection and processing
- Data collection
- Proficiency in Microsoft Office
- Problem solving
- Excellent attention to detail and organization
- Ability to multi-task and work in a fast-paced environment
- Ability to work independently and in a team environment
- Bilingual-Fluent in Spanish
Certification
Phlebotomy Certification
Timeline
Quality Control Specialist
Tiger BioSciences-RegenTX
09.2024 - Current
Phlebotomist/Donor Care Specialist
South Texas Blood & Tissue
03.2023 - 09.2024
Lab Assistant
University of the Incarnate Word
01.2022 - 07.2022
Bachelor's Degree in Biology
University of The Incarnate Word