Sandra Rodríguez
Senior QC Technician at Cocoon Bioscience- Claim this Profile
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Bio
Experience
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Cocoon Bioscience
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Spain
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Biotechnology
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1 - 100 Employee
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Senior QC Technician
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Jun 2023 - Present
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Ixaka
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United Kingdom
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Biotechnology Research
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1 - 100 Employee
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Quality Control Technician
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Jun 2022 - Jun 2023
- Flow cytometry, ELISA, cell cultures, blood cell counting, endotoxin detection, Gram staining… to verify the batch quality before release. - Management deviation events arising in the laboratory and problem solving through root cause investigation and CAPA implementation. - Updating of SOPs and forms, implementation of change control actions, new suggestions for improvement, e.g., time and document optimization… - Working on potency assay development and product characterisation - Flow cytometry, ELISA, cell cultures, blood cell counting, endotoxin detection, Gram staining… to verify the batch quality before release. - Management deviation events arising in the laboratory and problem solving through root cause investigation and CAPA implementation. - Updating of SOPs and forms, implementation of change control actions, new suggestions for improvement, e.g., time and document optimization… - Working on potency assay development and product characterisation
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Takeda
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Japan
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Control Technician
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Feb 2021 - Jun 2022
- Quality control in Cell Therapy products; mycoplasma test by qPCR, potency studies (HPLC), identity and purity analysis (flow cytometry) and endotoxin detection - Raw materials analysis: qPCR, glucose test, osmometry assays, pH measurement… - Documentation: lead investigation to deviation events and laboratory investigation, change control and CAPA (decision and implementation actions). Using TrackWise application - SOPs creating and modifying. Using LEADs application to documentation manage Show less
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ROVI Pharmaceutical Company
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Spain
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Control Technician
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Nov 2019 - Jan 2021
- Chemical Analysis (especially using HPLC with Empower software) - Documentation reviewing for batch release - Certificate of Analysis (CoA) - Chemical Analysis (especially using HPLC with Empower software) - Documentation reviewing for batch release - Certificate of Analysis (CoA)
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Meiji Pharma Spain, S.A.
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Spain
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Quality Control Technician
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Apr 2019 - Sep 2019
- Chemical and microbiological analysis - Updating standard operating procedures (SOPs) according to European Pharmacopoeia (EP) and United State Pharmacopoeia (USP) - Investigation of ‘out of specification’ (OOS) and ‘out of trends’ (OOT) results - Participating in the transference of new analytical methods - Chemical and microbiological analysis - Updating standard operating procedures (SOPs) according to European Pharmacopoeia (EP) and United State Pharmacopoeia (USP) - Investigation of ‘out of specification’ (OOS) and ‘out of trends’ (OOT) results - Participating in the transference of new analytical methods
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Education
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Facultad de Farmacia, Universidad de Salamanca
Máster Evaluación y Desarrollo de Medicamentos., Farmacia industrial y galénica/Cosmética -
Universidad Pablo de Olavide
Biotecnología