Loreta Rojas
@loretarojas
Biotechnologist specializing in QA/QC, GMP/GLP quality systems, and technical project management to drive operational excellence.
ArgentinaWhat I'm looking for
I’m a Biotechnologist with over 10 years of experience spanning quality control laboratories (QA/QC), research and development (R&D), and technical project management in regulated environments. I specialize in quality management systems under GMP, GLP, ISO 9001, and ISO 14001, with strong command of analytical method validation, SOPs, and deviation management (CAPA).
In my recent work, I perform physicochemical analysis under GMP and international pharmacopoeia standards, supporting material release decisions based on analytical data and compliance with technical specifications. I manage technical documentation and quality records, and I contribute to investigations and non-conformance handling while maintaining strict safety, hygiene, and quality requirements.
As a Senior Project Manager / consultant, I plan, execute, and close projects across multiple sectors—owning scope, schedule, budget, and risks. I coordinate multidisciplinary teams and stakeholders, build project plans, progress reports, and KPI dashboards, and facilitate corrective action plans when deviations, risks, or scope changes arise.
Earlier, I led a pilot plant and quality laboratory team, training and developing technical personnel while building a culture of safety, autonomy, and continuous improvement through measurable initiatives like 5S. I ensured inspection readiness through internal and external audits, managed documentation and regulatory reporting traceability, oversaw compliance for ISO 9001, ISO 14001, and GLP/GMP, and integrated R&D and scale-up to align research outcomes with production needs.
Experience
Work history, roles, and key accomplishments
Senior Project Manager
Independent Consultant (Lumenlab)
Jan 2023 - Present (3 years 5 months)
Planned, executed, and closed projects across multiple sectors, managing scope, schedule, budget, and risks. Coordinated stakeholders, tracked progress with KPI dashboards, and implemented corrective action plans for deviations and scope changes.
Quality Control Analyst
Teva Pharmaceutical
Dec 2025 - Feb 2026 (2 months)
Performed physicochemical analysis of raw materials and finished pharmaceutical products under GMP and international pharmacopoeia standards. Supported material release decisions, quality record/documentation management, and quality investigations and non-conformance handling.
Pilot Plant & Lab Coordinator
Tecsan – Benito Roggio Ambiental
Jan 2019 - Jan 2023 (4 years)
Led laboratory and pilot plant teams, training staff and building a culture of safety, autonomy, and continuous improvement. Coordinated scale-up assays and analytical schedules while ensuring compliance with ISO 9001, ISO 14001, and GLP/GMP through audits, SOPs, traceable documentation, and CAPA-driven actions.
Quality & R&D Analyst
Tecsan – Benito Roggio Ambiental
Jan 2016 - Jan 2019 (3 years)
Executed physicochemical and microbiological analyses for process control and environmental samples. Developed, validated, and optimized analytical methods (UV-Vis/spectrophotometry and ICP) and supported the quality management system implementation under ISO 9001/ISO 14001, including SOP drafting and regulatory collaboration.
Graduate Researcher
Bioremediation Research Institute 3IA – UNSAM
Jan 2014 - Jan 2016 (2 years)
Conducted bioremediation research using Botryococcus braunii, designing and executing reactor assays and optimizing culture conditions. Applied ICP and UV-Vis for hydrocarbon quantification, performed statistical analysis, and disseminated results through international publication and conference presentations.
Physicochemical Lab Analyst
LADIAC S.A.
Jan 2012 - Jan 2014 (2 years)
Performed physicochemical, microbiological, and toxicological analyses for raw materials, water, and products with full result traceability under GMP and ISO 9001. Coordinated daily tasks and supervised two junior analysts, supported regulatory audits, and managed toxicology and sensory evaluation activities.
Sub-Area Coordinator
Techo Argentina
Jan 2007 - Jan 2010 (3 years)
Coordinated social projects and managed teams of over 10 people, including logistical oversight and quality control of materials. Ensured day-to-day coordination within applicable project processes and team workflows.
Education
Degrees, certifications, and relevant coursework
National University of San Martin (UNSAM)
Bachelor's Degree in Biotechnology, Biotechnology
Bachelor’s degree in Biotechnology at the National University of San Martin (UNSAM), Institute 3IA.
National Technological University (UTN)
University Expert in Project Management, Project Management
University Expert program in Project Management at the National Technological University (UTN).
FEFyM University
Clinical Trial Monitoring (ICH/GCP), Clinical Trial Monitoring
Clinical Trial Monitoring course focused on ICH/GCP standards.
National Technological University (UTN)
University Expert in Ethical Hacking, Cybersecurity
University Expert program in Ethical Hacking at the National Technological University (UTN).
Tech stack
Software and tools used professionally
Availability
Location
ArgentinaAuthorized to work in
Job categories
Skills
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