Samarie Hernández Navarro
Cidra,PR
Summary
Dynamic manufacturing professional with extensive experience at Amgen Manufacturing Limited, showcasing adaptability and operational excellence. Adeptly manage cross-functional collaborations and leverage expertise to drive process improvements and team success.
Overview
10
10
years of professional experience
Work History
Associate Mfg
Amgen Manufacturing Limited
07.2019 - Current
- Adhere to GMP and all applicable regulations, policies, and procedures for health, safety, and environmental compliance.
- Support Change Controls, CAPA, deviations, validations and new product introduction.
- Collaborate with cross functional areas such as Quality, Engineering, MES and Automation to verify and define equipment’s alarms and tolerances, creation and revision of BOMs, creation and revision of electronic batch records, and execution of Media ACO.
- Provide training and collaborate with Training department with the revision of AV, TRNQ and TRN.
- Set up, operate and monitor fermentors, during batching and production, cell culture process, filtration skids, and chromatography columns.
- Prepare small, and large volume Media and Buffers.
- Perform analytical testing for in process and final product release samples such as pH, Conductivity, Protein Concentration, Endotoxins and Osmolality.
- Author, edit, review and approve documents (SOP, FORM, APPX, MET, RPT) in CDOCS Document Management.
- Data verification, review and approval of analytical testing invalid rate reports.
- Create, review, reconcile and destroy documentation logbooks as necessary during the manufacturing operations.
- Review process of Electronic Batch Record (EBR) revision and closure process.
- Provide recommendations during process or equipment troubleshooting.
- Support Operational Excellence by contributing OPL, Bin Items, Raise your Hand.
MFG QA Auditor
Janssen Ortho
03.2018 - 07.2019
- Review batch records ensuring compliance of product specifications, cGMP, ad SOP before a batch is released, distributed or rejected.
- Attend floor situations and assist with solving potential compliance issues in accordance of current procedures.
- Participate in Triage Meetings, and make the appropriate recommendations and decisions to prevent process and product deviations.
- AQL inspections.
- Initiate, evaluate, close and promote to investigation Trackwise events once a deviation or nonconformance has been identified.
Associate Mfg
MSSS, Inc
11.2014 - 12.2017
- Set up and operate equipment, such as Labware Washer, COP Bath, Autoclave, in accordance with cGMP and SOP.
- Perform CIP/SIP cycles using PCS.
- Filter integrity testing.
- Collect samples and initiate chain of custody using LIMS.
- Trains staff to perform hands-on operations.
Education
Bachelor of Science - Cell And Molecular Biology
University of Puerto Rico
Rio Piedras, PR06-2014
Skills
- Teamwork
- Adaptability and Flexibility
- Organization and Time Management
- Operational Excellence
- CDOCS, LIMS, eBR
- Information Mapping, MS Word, MS Excel, MS PowerPoint
- Fluent in Spanish and English
Timeline
Associate Mfg
Amgen Manufacturing Limited
07.2019 - Current
MFG QA Auditor
Janssen Ortho
03.2018 - 07.2019
Associate Mfg
MSSS, Inc
11.2014 - 12.2017
Bachelor of Science - Cell And Molecular Biology
University of Puerto Rico
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