SUSANA HERNÁNDEZ SANTOS
Morovis,DC
Summary
QC Analyst with more than 8 years of experience in the Pharmaceutical Industry. Specialized in sampling, inspection, physical, functional and chemical testing of API's, raw materials, and packaging components, primary and secondary, for both solid and biopharmaceuticals products. Committed to continuous process improvement, problem solving and quality assurance at every stage of the production cycle.
Overview
10
10
years of professional experience
Work History
QC Incoming Analyst
Bristol Myers Squibb
Manati
01.2018 - Current
- Responsible for sampling, testing of all components (Printing, Packaging, Medical Devices, Material Requirement Sheet (MRS), Sterile Materials) and sampling of all excipients, drug substances and API for the use of the manufacturing and packaging areas to assure with the regulations of FDA and all markets
- Perform and check the required testing of materials and products in accordance with BMS specifications
- Knowledge in systems Sap, Lims, Infinity
- Active participation in team meetings provides input on simplification and improvement projects
- Revise and approve documents: forms, SOP's, and Technical Documents in Veeva Vault and DCA Systems
- Support actions for CAPA's, and protocols for new materials introduction and validation
- Trainer certification provides training for new members, task and SOP's
QC Laboratory Analyst
Pfizer
Vega Baja
01.2015 - 01.2017
- Performs a variety of basic to complex analytical laboratory testing of finished products and specials project samples
- Understand most procedures within the assigned laboratory and associated production areas, following established procedures and techniques
- Knowledge of Current Good Manufacturing Practices, QC Laboratory Standard Operating Procedures and Safety requirements
- Also, as assist in scheduling of work and review/ approval of laboratory data
- Receive, log samples in SQL Lims, G-Lims and electronics logbooks
- Uses automated system (empower, Lims, GLims)
- Check laboratory data, as required
- Participate in performing related inspections, including GMP's inspections and audits
- Maintains and operates laboratory equipment (HPLC, GC, Analytical Balances, PH meter, Dissolution Baths) and recognized malfunction
Education
BA - Sciences with Chemistry concentration
Bayamon Central University
01.2011
Biotechnology Certification -
Universidad de Puerto Rico
01.2006
Skills
- Strong customer service skills
- Teamwork oriented
- Problem Solving
- Critical Thinking
- Compliance Mindset
References
Available upon request.
Timeline
QC Incoming Analyst
Bristol Myers Squibb
01.2018 - Current
QC Laboratory Analyst
Pfizer
01.2015 - 01.2017
BA - Sciences with Chemistry concentration
Bayamon Central University
Biotechnology Certification -
Universidad de Puerto Rico
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