Quality Control Supervisor / Quality Control Manager / Senior R&D Chemist: Strong skills & SAME in LC Waters Alliance & UPLC Empower Data Acquisition System . SAME in Agilent GC & skills in addressing any Agilent GC issues & troubleshooting. Skills in Fisher Scientific Ion Chromatography ICS 5000 SP,EG & DC. SAME in GC Perkin Elmer Clarus 500 GC & PE Clarus 500 GC-MS. Familiar with TLC,PE FTIR Spectrum 100,795 Karl Fisher Titrino with 703 Ti Stand & Key Pad, Familiar with AA,Flame Photometry,UV-Vis,GMP,S.O.P & NF.PE( ICP ) Optical Emission Spectrometer
Overview
26
26
years of professional experience
Work History
Quality Control Supervisor
Nestle Health & Science / Nature Bounty
Bohemia, NY
02.2011 - Current
Responsible for laboratory personels , conducting & overseeing quality control & collecting analyzing and interpreting lab results .
Collaborating with senior managers to establish strategic plans and objectives for a full " Data Integrity " protocol .
Maintain active role on internal continuous improvement of our teams,Proposing & implementing inspection criteria.
And procedures where it may be inadequate or lack of. .
Sharing technical and statistical expertise to all qualitative and quantitative questions that may arise from a test method or instrumentation or calculation .
Apply total quality management tools and approaches to analytical and reporting processes.
Guide junior chemists & technicians engaged in inspection and analytical testing activities to ensure high productivity and high technical integrity.
Training,guiding & mentoring senior & junior chemists on various instruments such as :Gas Chromatography,UPLC & HPLC & PE Clarus 500.
Interpreting data and adhering to strict guidelines on documentation when recording data .
Training associates on reporting scientific results using a range of analytical techniques,instrumentation & software.
Working collaboratively with upper management in the training of senior & junior chemists in,lab book checking,GMP,GLC,S.O.P,safety and Data Integrity.
Optimizing analytical methods techniques for the analysis of drugs products and chemicals .
Quality Control Manager
Corwood Laboratories INC
Hauppauge, NY
08.2002 - 10.2009
Led,supervised,developed & motivated 9 analytical chemists from training to mentoring to performance improvement.
Help associates achieve peak performance during impactful organizational changes .
Maintained laboratory workflow and established priorities and time lines for Quality Control & critical component Manufacturing groups
Ensuring associates are compliant to quality standards,productivity goals and deliverables achieving > 95% OTIF .
Strategically scheduled testing activities,managed execution of methods and procedures for inspecting , testing and evaluating product quality
Initiated and led investigations for non-conforming and out of specification material through OOS,NCR and CAPA reporting processes.
Organized and run troubleshooting meetings , established experimental plans and provide resolution into root cause analysis .
Established,managed and maintained precise QC standards and participated in audits to ensure compliance to GMP,GLP,ISO9001 and FDA regulations. .
Prepared,designed and reviewed documents or new analytical testing methods to be submitted to the FDA .
Apply total quality management tools and approaches to analytical and reporting processes Document writing .
Develop & analyze statistical data and product specifications to determine standards and to establish quality and reliability expectancy of finished products.
Responsibility for QA / QC functions for testing complaint handling,FDA problem resolution .
Create,document,S.O.P and implement inspection criteria and procedures.
Review & analyze reports,records and directives & confers with managers to obtain data required for planning activities
Such as new commitments,status of work in progress and problems encountered.
Investigate and correct customer issues and complaints relating to quality.
Supervise inspection and testing activities to insure high productivity.
Formulate , document and maintain quality control standards and on-going quality control objectives .
Senior R&D Chemist
Altana Inc
Melville, NY
08.2000 - 08.2002
Develop & validate methods for experimental drug candidates
Write and review method transfer protocols and method S.O.P
Perform characterization studies for impurities,degradants,intermediates and active components of drug substances and drug product.
Develop and analyze statistical data and product specifications.
Deliver innovative solutions for aggregate safety strategy & analyses .
Education
BS - Chemistry
York College CUNY
Jamaica Queens, NY
Organic , Inorganic and Physical Chemistry
Brooklyn College SUNY
Brooklyn, NY
Skills
Proactive safety support
Knowledge of drug safety principles
Proficient in data processing software
Analysis of scientific and technical data
Functional knowledge of Excel,Power Point,Microsoft Word