Agustina López

I am an enthusiastic, highly motivated and professional person with a strong work ethic and commitment to safety. I can offer experience working within laboratories and am comfortable with the use of specialist equipment and technology.

Transferable skills and abilities:
- Proven organizational and time management skills with ability to use own initiative and prioritize tasks. 
- High attention to detail, able to apply logistical thinking.
- Capable of applying sound and consistent judgement in decision making processes and lead by example.
- Strong communication skills; able to convey information in both written and oral format in an impartial and clear manner.
- Strong ability to create rapport and engage with people from diverse backgrounds in a professional manner.
- Highly effective working within high pressure situations. 
- Strong ability to adapt to new working environments and able to adjust to changing conditions.
- Supportive team member, confident working autonomously and accepting responsibilities.
- Passionate about quality and process improvements.

THG Labs                                                                                                                                                                       2024

Quality Systems Technician

• Support GMP compliance by conducting environmental monitoring, FDA swabbing, and managing traceability documentation.
• Microbiological reports review, addressing out-of-specification results, and performing root cause investigations.
• Assistance with internal and external GMP audits, risk assessments, and continuous improvement initiatives.
• Sample logging, dispatching to ALS, and updating microbiological results in the micro log system.
• Creation and updates of SOPs. 
• Assistance with NCRs, and FDA compliance documentation.
• Training staff on swabbing techniques and maintaining a positive, collaborative team environment.

PlusLife (Perth Bone and Tissue Bank)                                                                                                     2023 - 2024

Quality Officer

• Provided support with administrative function in the development, implementation and maintenance of the Quality System, that meets and exceeds regulatory legislated requirements.
• Partake in risk management processes including non-conformances, assessment, correction and monitoring processes in co-operation with the QM.
• Report compilation.
• Develop and create periodic reviews reports verifying the performance of products, processes, facilities.
• Authorise the release of conforming tissue for processing and allograft for implant.
• Dispatch – follow up samples for external texting.
• Maintenance of production equipment and consumable items.
• Coordinate change control initiatives within the quality area and participate in change initiatives lead by other departments.
• Document and record management – creation, review and approval.
• Experience with Q-Pulse – electronic Quality Management System.
• Experience with InnoTech software - Facility Management system.
• Assistance to the team in preparation to internal and external audits in line with TGA Code of Good Manufacturing Practice – Human Blood and Tissues. 
• KPI’s development and data collection.

OrthoCell Pty Ltd                                                                                                                                            2022 - 2023

Senior Laboratory technician

• Manage and execute daily lab tasks to ensure smooth operations and compliance with protocols.
• Manage and maintain lab equipment, ensuring proper functioning, and coordinate repairs and replacements as needed.
• Staff’s training and supervision under ISO 13485 regulations.
• Prepare and maintain lab reagents and solutions, and responsible for monitoring supply inventory and communicate ordering needs.
• Identifying anomalies in analytical results and assisting with the investigation of non-conformances.
• Follow up and contribute to the creation of work instructions and standard operating procedures.

CareDx Pty Ltd                                                                                                                                                2020 - 2022

Laboratory technician-Team Leader

• Planning manufacturing and operations schedule according to fluctuated forecast
• Staff’s training and supervision under ISO 13485 regulations.
• Distribute reagents across critical process in an effective manner by minimizing waste 
• Laboratory daily duties including equipment calibration and general maintenance
• Organise and manage stock – Ordering and shipping products. 
• Experience with Oracle NetSuite - inventory management system.
• PCR – Environmental testing.
• Assistance to Quality team in preparation and during  internal and external audits (ISO 13485)

Laboratory of Evolution : Barcode of Life Project                                                                                    2013-2015

Research Assistant

• Prepare arthropod traps, collect and analyse data
• Identify specimens and prepare entomological boxes
• Take DNA samples
• Centrifuging and pipetting samples 
• Write regional reports, track documentation and photo analysi

  Bachelors degree on Biological Sciences