Business Analyst Resume Irvine, California - Hire IT People

SUMMARY:

Expert in software development life cycle, including analysis, design, development, testing and implementation of software applications in a regulated environment.
Trained in IT, R&D, QC processes in compliance to FDA regulations and guideline.
Always performs in accordance to GxP guidelines.
Extensive knowledge of Empower, ELN, NuGenesis, Chemstation, and LIMS systems.
Extensive knowledge with USP/EP/JP pharmacopeias.
Excellent communication, analytical, interpersonal, and presentation skills.
Strong ability to work in teams and collaborations.

TECHNICAL SUMMARY:

Laboratory Software: Empower, NuGenesis SDMS, ELN, Vision Publisher, LIMS, Chemstation, Chemstore, Tiamo, STARe, Chromeleon, Color Quest

GUI/Tools: Visual Basic, Excel, Word, Access, Trackwise, WISDOM, Documentum, Master Control

Platforms: Windows, MSDOS, Linux

Testing Tools: Test Director, PUP (for Excel sheet validation)

PROFESSIONAL EXPERIENCE

Business Analyst

Confidential, Irvine, California

Responsibilities:

Defines business requirements, user - requirements, functional requirements, stake holder requirements, and processes with departments to optimize performance efficiency.
Develop, design, code, validate, test, and implement software tools to maximize efficiency in R&D laboratories.
Implements updates, fixes, and maintenance on software systems which includes formal documentation and change controls processes for system changes in a regulated environment.
Conducts business analysis, project assessments and feasibility determinations.
Trains end users in systems and process workflows in software systems such as for ELN, Empower, LIMS, and Chemstore.
Works with technical staff to support laboratory systems such as ELN, Empower, NuGenesis, LIMS, Chemstore, Chemstation, and stand alone instruments in the R&D and QC labs.
Serves as a R&D IT representative for FDA, internal, and global audits.
Administrator to Empower, LIMS, NuGenesis, ELN, Chemstore, Chemstation systems for R&D.

R&D Scientist

Confidential, Irvine, California

Responsibilities:

Conducted method-development and validation studies.
Performed R&D stability testing and method transfers to QC.
Performed chemistry testing according to USP/EP/JP monographs and their respective regulations.
Wrote validation reports, protocols, and numerous SOPs for laboratory methods and processes.
Daily use of Empower, NuGenesis, and Chemstation software.

QC Chemist

Confidential, Irvine, California

Responsibilities:

Conducted daily in-process testing of pharmaceuticals through HPLC, GC, and wet chemistry methods according to the USP, EP, and BP in a regulated environment.
Daily use of Agilent, Waters, and Alliance systems and programs.
Released in-process lots in tight time constraints, usually in 1-2 hours in a regulated environment.

Quality Control Chemist

Confidential, Manhattan Beach, California

Responsibilities:

Performed Environmental testing and chemical analysis using EPA and Standard Methods.
Developed new methods and techniques in accordance to EPA protocols.

Quality Control Chemist

Confidential, Garden Grove, California

Responsibilities:

Performed raw material, in-process, finished product and stability testing using USP/NF.
Calculated and determined quality of vitamins by HPLC, ICP, IR/UV spectrometry.
Worked in a GMP/GLP environment.