Nicole Vázquez Miranda
Summary
Enthusiastic Molecular Biotechnologist with 3 years of experience in the biopharmaceutical industry. Competent in lab techniques, quality control analysis, raw material sampling, and upstream manufacturing process with focus on critical issues and results, to fulfill the organizational objectives.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Associate Manufacturing
Amgen
01.2022 - Current
- Prepared and operate equipments such as bioreactors.
- Performed equipment preparation, and preventive test before each lot, such as pressure test, and steam in place ensuring tanks are running smoothly.
- Adjusted tanks settings or controls under procedures in preparation for production operations.
- Performed everyday calibration on critical instrumentation, guaranteeing accurate measurement for important process parameters.
- Proficient in performing assembling/disassembling equipments to meet production requirements and daily established quotas.
- Participated in troubleshooting activities when problems arise during manufacturing process or equipment preparation in order to prevent delaying production schedules.
- Participated in activities such as media addition and inoculation of tanks.
- Involved in critical process such as monitoring, sampling and testing of cell culture.
- Consistently comply with production targets through time management, prioritization of tasks, and collaborating closely with team members.
- Performed pH and dissolved oxygen standardization in bioreactors.
- Worked with high degree of attention to detail preventing any deviation.
- Maintained accurate documentation of batch records and equipment logs ensuring traceability throughout manufacturing process.
- Collaborated with team members, and Quality Assurance teams, to review batch records for faster release of lots.
- Recognized and report any non-conformance to manager.
- Supported training of new team members by sharing knowledge and providing guidance.
- Replenished materials and supplies as needed on everyday production.
- Performed regular maintenance on equipments such as Blood Gas Analyzer, Osmometer, Cedex, YSI for optimal performance on in-process testing.
- Used of sterile tube welders, weight objects and aseptic connectors for manufacturing process.
- Performed filter integrity test on Sartocheck equipment.
- Qualified in Alternating Tangential Flow (ATF) filtration method.
- Used of computer operations such as PCS, Electronic Batch Record (EBR), LIMS and PI-Batch for monitoring and documentation of production process.
Associate Quality Control
Amgen
09.2020 - 12.2021
- Reviewed batch record documents to ensure data is accurate and complies with SOP, and reported any non-compliance issues.
- Evaluated supplier documentation against established criteria, ensuring consistent delivery of high-quality raw materials for manufacturing operations.
- Performed routine laboratory procedures such as equipment calibration; and disinfectant preparation for sanitization and cleaning of materials.
- Sampled raw materials chemicals and excipient for characterization, microbiology testing, and reserve samples, according to test methods to ensure quality control.
- Performed test and inspection of raw materials and compared against specifications to meet regulatory requirements.
- Performed sample management for laboratory testing.
- Participated in Controlled (clean) Rooms sanitization avoiding any contamination.
- Performed data entry, review and authorization of sample testing results, and communication of results for material disposition.
- Contributed in forms improvements initiatives to help reduce errors in documentation.
- Established priorities using time management techniques to complete area tasks on time and comply with business goals.
- Completed work with high degree of attention to detail avoiding any non-conformance issues.
- Participated as leader, helping and supporting team members to comply with business priorities and area tasks.
- Contributed to successful completion of external audits by providing accurate documentation.
- Fulfill with safety guidelines, Good Manufacturing Process, and regulatory requirements.
- Used of electronic systems such as: SAP, Trackwise, LIMS, BTRS, Coldstream systems and Smartsheet.
- Worked effectively and collaboratively across teams and level of management.
- Qualified in:
• Gowning of Controlled Rooms: Level 1 and Level 2
• Controlled Rooms Sanitization: Down Flood Hood and Fume Hood.
• Raw Materials Sampling of Tested Materials.
• Inspection of Chemical Raw Materials.
• Controlled Rooms Sanitization: Class 8 and Class 9
• TruScan RM Handheld Raman Analyzer
• Sampling of Drug Product, Intermediate Drug Product and Drug Substance.
Education
Master of Science - Molecular Biotechnology
Interamerican University of Puerto Rico
Bayamón, Puerto Rico05.2020
Bachelor of Science - General Biology
University of Puerto Bayamon Campus
Bayamon08.2018
Skills
- Time Management
- Effective communication
- Self-Motivated
- Strong Collaborator
- Ability to Work Under Pressure
- Ability to Multitask
- Microsoft Office
- Problem Solver
- Analytical Skills
- Quality Control
- Adaptable learner
- Attention to detail
- Positive Attitude
Certification
Microbiology in the Pharmaceutical Industry, Biobusiness Research Institute (June 2017)
QA Academy, Amgen (Nov 2021)
Timeline
Associate Manufacturing
Amgen
01.2022 - Current
Associate Quality Control
Amgen
09.2020 - 12.2021
Master of Science - Molecular Biotechnology
Interamerican University of Puerto Rico
Bachelor of Science - General Biology
University of Puerto Bayamon Campus
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