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Rose Castro personal email
Professional with 10+ years of experience in Quality in the Pharmaceutical Industry. Knowledgeable in CGMP, GCP, GDPs. Proficient with USP/NF methodology, Master Control, Trackwise, Veeva Vault and SAP. Quick learner and able to multi-task adapting to changing priorities. Highly organized and self-motivated. Bilingual with excellent interpersonal skills.
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Qa AuditorWorldwide Clinical TrialsCharlotte, Nc, Us -
Gxp Associate IiAllucent Jun 2022 - Present -
Sr. Quality Auditor & Laboratory SmeBright Path Laboratories Dec 2021 - Jun 2022North Carolina, United States -
Team Lead Qc StabilityGlenmark Pharmaceuticals Jul 2021 - Dec 2021United States• Oversee the execution of stability protocols for FDA ANDA, from the initiation to the termination of the protocols. • Preside over the work of QC Analysts. • Coordinate with QC Management for scheduling of stability sample analysis.• Maintain knowledge of current regulatory requirements and standards as they pertain to the Stability department. • Support the FDA ANDA submission of 6+ products by ensuring the data is managed and evaluated to meet company, industry and regulatory requirements.• Trained and mentored 20 new hires in the laboratory within a 15-month period. • Pioneered the use of Micro Control Solutions (a 21 CFR part 11 complain software) for stability protocol handling and data tracking. -
Qc AnalystGlenmark Pharmaceuticals Feb 2019 - Jun 2021Monroe, North Carolina• Complete laboratory investigations following current GDPs.• Assist the R&D department with 4+ method transfers for new products to the site. • Responsible for analyzing oral solid dose (OSD), prefilled syringes/vials and sterile nebulizer products to support the Stability group and the Finish Product group. • Established a storage process for the laboratory improving solution prep efficiency by 25% • Awarded Employee of the month for September 2020 -
Chemist IiCorerx, Inc. Oct 2015 - Dec 2018• Responsible for Clinical and Commercial testing for in process, release and stability samples as well as raw material. • Supported a new product from the developmental stages until commercial stability, including but not limited to validation of processes, method transfer and testing. • Completed peer review ensuring compliance in a cGMP environment. • Conducted laboratory OOS investigations in addition to completion of CAPA plans. • Drafted, revised and approved Protocols, SOPs and Test Methods to reflect current practices and cGMP Standards as subject matter expert. • Reported experiments directly to client, representing the analytical department with outmost integrity. • Skilled in HPLC, GC, UV-Vis, IR, Dissolution bath, TOC, Wet Chemistry assays, Biochemical assays among others. • Trained new hires in very specific lab instruments and techniques such as Protein ELISA and Protein Content by Dumatherm. • Coordinated workload sharing with team members to meet deadlines as project team lead. • Developed HPLC method for a new allergen drug with little guidance from client.• Validated new analytical methods for new allergen drug in a short period of time. -
Quality Control Analyst-Olay LlcProcter & Gamble Sep 2012 - Jun 2015Cayey, Puerto Rico• Responsible for raw material and finished product analysis using R&D’s and USP methodology. • Participated in cleaning validations and method transfers for the analytical laboratory. • Developed SOP’s and Job Safety Analysis for critical laboratory processes following current GMP’s. • Performed routine maintenance of laboratory equipment as a member of the Autonomous Maintenance Pillar. • SPOC for the 5S system in the laboratory and GC subject matter expect.• Coached new hires and completed the laboratory training to 100%. • Supported the laboratory to comply with OSHA regulations as SFL (Safety Functional Leader).• Received the HPO Awesome Award for using the High-Performance Organization tools in the laboratory in 2014.
Rose Castro Skills
Rose Castro Education Details
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Natural Sciences
Frequently Asked Questions about Rose Castro
What company does Rose Castro work for?
Rose Castro works for Worldwide Clinical Trials
What is Rose Castro's role at the current company?
Rose Castro's current role is QA Auditor.
What is Rose Castro's email address?
Rose Castro's email address is ro****@****cent.io
What schools did Rose Castro attend?
Rose Castro attended Universidad Del Sagrado Corazón.
What skills is Rose Castro known for?
Rose Castro has skills like Fully Bilingual English, Multitasking, Leadership, Cgmp Practices, Elisa, Time Management, Good Laboratory Practice, High Performance Liquid Chromatography, Gas Chromatography.
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Rose Castro
Mesquite, Tx -
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