Quality Assurance Manufacturing
Resume:
JUAN CARLOS SLEIMAN JR
**** * ****** ******* **, 33014
*************@*****.***
OBJECTIVE
To obtain a career in the Pharmaceutical Quality Assurance field, utilizing the skills and knowledge I have acquired throughout my years in the industry.
SKILLS PROFILE
Extensive GMP knowledge.
Batch record final review and issue.
Knowledge of Quality systems and FDA regulations.
Proficient in the use of JDE, Trackwise, livelink, SAP LIMS,and Master Control.
Computer literate with proficiency in Microsoft Word, Microsoft Excel and Adobe.
Exceptional organizational skills and attention to detail with minimal supervision.
Opex White Belt and Yellow Belt Certified.
Member of process optimization team.
Routing Deviations and CAPA Assignments as well as Change controls, SOP’s and Regulations.
APR and Customer complaints.
EMPLOYMENT HISTORY
BioTest Pharmaceuticals
Quality Assurance Specialist 2014 - current
Final review and issue of manufacturing records.
Originate Deviations, CAPAS change controls, and assist with closing and routing for approval.
Track open Quality systems and assign priority to route for closure before due date using Lims software.
Work with process optimization team on projects to improve manufacturing process.
Manufacturing over sight and daily audit for FDA Readiness and adherence to GMP.
Actavis (Teva)
Quality Assurance Specialist 2010-2014
Originate and Issue manufacturing batch records.
Manage all retain samples including controlled substances.
Monitor manufacturing parameters and conditions for stability and product safety.
Raw Material Sampling including potent compounds, actives and excipients.
Handle customer complaints and generate proper documentation of the results through lims tracking.
Generate and manage Annual Periodic Reviews and stability samples
Merck & Co
Quality Assurance Inspector 2007-2010
Review and issue manufacturing batch records.
Ensure personnel adhere to strict GMP Guidelines.
Investigate deviations and root cause analysis for process optimization.
Assist with open quality system (Deviations, Qualifications, and revise Sop’s).
EDUCATION
Monsignor Edward Pace High School 2002 - 2006
Miami Dade College 2015 - Current
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