NITA MARU

**** ****** **., *********, ** *****

Phone: 714-***-**** ° Email: gcu1n9@r.postjobfree.com

OBJECTIVE: Seeking a challenging position as a Quality Engineer or QA Scientist.

EXPERIENCE:

Beckman Coulter, Inc. Fullerton, 2005-2009.

Technical Operations Scientist

 Constantly identify, develop and enhance a wide breadth of technical skills through new projects. Take on the functional responsibility of large tasks of known duration and effectively utilize resources available to accomplish the department goal. Provide assistance and guidance within work team to resolve major production technical issues for the GeXP and CE product like such as pUC18, Neutral Capillary, HS-Cyclodextrin.

 Broad based technical knowledge and skills in diverse areas of business and have experience in tactical regulatory, quality systems, and business knowledge to identify, investigate and resolve customer complaints.

 Applied statistical tools (Six Sigma, Pareto charting) as the application of systemic and investigative tools to evaluate product quality attributes and failure modes.

 For multiple product line was responsible for investigating customer complaints for product quality issues and concerns, including the preparation of written failure investigations. Researches device history records associated with the manufacture of the product.

 Have worked on investigations and with technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA, and subsequent closure of investigations.

 Apply project management tool to plan and provide the technical and logistic support to manufacturing. Work extensively with external vendors and Procurement to improve processes to align with business objectives of quality, cost and services.

 Provide technical leadership and support to assigned operational areas (product development and manufacturing) including an objective microbial quality assessment.

 Act as a back-up supervisor as well as a back-up technician, as needed, for all technical procedures such as sterilization of equipments, environmental monitoring and water system evaluation, cell culture, endotoxin testing..etc in the Microbiology Lab.

 Conduct process qualification, validation and internal audits for production lab and have provided guidance as quality control, sterilization, product safety, aseptic condition control and other areas affecting product / process compliance. Project coordination includes, but not limited to, plans, data collection, study design, implementation analysis, conclusion recommended course of action and documentation of all aspects for these projects.

 Independently plan and implement changes designed to improve performance of existing products as well as introduction of new products. Participate in new product design reviews and provide direction within the area of expertise.

 Coordinate and plan the piloting, testing and releasing of new products. Act as a liaison between functional groups to facilitate the transfer of new product from R&D to manufacturing. Writes low complexity procedures, protocols and reports. Provide technical input, developing, formulating and packaging processes. Perform qualification of outside vendors, characterization of raw materials, and procurement of raw materials and utilization of personnel. Schedule each phase of transition form R&D to production, and train production personnel for manufacturing readiness. Maintain and update documentation regularly to meet ISO, GMP and FDA requirements.

 Resolve Customer Feedback and CAPA issues. Participate in technical decisions affecting tools, equipment, processes, and product modules. Identify critical issues and investigate alternatives. Recommend and develop implementation plan for resolution.

 Investigate Manufacturing and CAPA issues by generating and execute test plans. Use Six Sigma tools (DOE, GRR, FEMA etc.) and statistical analysis to analyze results, and present data and reports for approval.

 Design and perform experiments to resolve GeXP and CE issues with hand-on experience with PCR, DNA/RNA preparation, and CE.

 Successfully managed the reagent design transfer of the following projects from Development to Manufacturing:

o PF2D Test Mix

o GeXP 5X PCR Buffer and other products

o OEM PF2D Buffer and Column Kit

o OEM Chimlib Microplate

o Piezo NPT1 Tip

o Neutral-A Capillary

 Trained QC Chemist in testing and Production Chemist on the formulations.

 For new project and processes, create routers, performed cost analysis for new parts transferred to manufacturing, initiated Pilot Authorization and write & execute validation protocol and reports. Successfully performed equipment and process validation methods; IQ/OQ/PQ.

 Participated as lead for assigned special projects.

 Successfully transferred new OEM products for costumers and have lunched new reconfigured kit structure.

 Providing line maintenance for product line with more than 200 formulations, which includes-initiates, designs, develops and implements. Reviewed and implemented necessary change orders for manufacturing documents for assigned product line.

 Providing Admin support for department to maintain DID3 system and global CAPA and have participated in CPI team to improve process and cut cost.

 Part of CF/CAPA team and investigate field issues and write reports. Assists customer’s issues on product performance; teams with Engineering and other departments to troubleshoot instrument and Chemistry problems; assists with product definition and specification development; develops and executes test protocols to assess feasibility of product modifications; and prepares reports and related documents.

 Through six sigma projects and CPI efforts, drive site quality action plans to meet major quality performance goals. Supported all Line maintenance activates for HPLC production. Also, with LEAN Activities successfully reduced cost & labor hours.

Beckman Coulter, Inc. Brea, 2004-2005

Development Scientist (Professional)

• Worked on DXC Project of New generation Clinical Analyzer for Beckman Coulter (DXC 600/800 & Access & DXCi).

• Performed experiments as defined and planned; reviewed test results for experimental errors and determined if repeats are required

• Performed and carried out all difficult tasks of validation for Hardware and software protocols. Maintain Clinical Laboratory, calibrate, QC & maintain instruments in the lab.

• Participated in planning studies for the development, evolution and optimization of assay(s).

• Participated in the analysis, design and development of system application.

• Maintained well organized laboratory notebooks in compliance with relevant procedures; and supported post-launch to resolve performance and quality issues.

• Provided quality assurance for adherence to technical standards.

• Team player on DXC project and expert in all laboratory techniques.

Westcliffe Medical Laboratory, Inc. Fullerton, 1992-2002

Laboratory Technician/Associate

• Performing Beta qual, cold agglutination, Occult blood, Mono, Urine Analysis, CBC, and Chemistry Panels and blood processing, gel electrophoresis, genetic analysis, protein electrophoresis.

• Performing vein-puncture for patients of all age group including infants.

• Design and implementation of quality improvement programs and Interpret results.

• Assisting in all aspects of laboratory care services and general office functions.

• Conducting laboratory audits and chemical purchasing.

Professional Laboratory Services Fullerton, 1991-1992

LAB Assistant

• Responsible for Blood testing including setting up all types of cultures, O&P, Occult blood, performing RPR, RA, Mono, Urine Analysis, Sedrate, CBC’s

• Performed phlebotomy on all age group including infant.

• Received patients and data entry, call and Fax results to all doctors offices

• Provided Quality Assurance reports and assisted in patient billing

BIO MED LABS, INC. FULLERTON, 1989-1991

Lab. Technician

• Responsible for Microbiology assistant-set up of all types of cultures including Chlamydia.

• Ran thyroid panels, Ferritins, ANA, CBC’s, Sedrate, RPR, and RA.

• Blood Processing.

• Preformed proficiency testing.

• Performed Phlebotomy services.

EDUCATION:

BS in Biology, California State University, Fullerton, 2002

BS in Chemistry, University of Bombay, India, 1989

Training Courses Beckman Coulter, Inc.: MDQ analyzer- Introduction course; Corner Stone; Project Management; Six Sigma; Lean Six Sigma; CPI; ISO and GMP courses.

LABORATORY SKILLS:

Cell Culture, RNA & DNA extraction, Cell Biological techniques, Molecular Biology techniques, Protein purification, Multi channel pipetting, Elective work in: Biology of Cancer, Virology, and Microbiology, Biochemistry: Basics of spectrophotometer, pH and buffer preparation, methods of protein determination, principles and uses of chromatography, enzyme assay, theory and measurement of radioisotopes (liquid scintillation counting), and SDS-gel electrophoresis, theory of centrifugation.

Biology: Hematology, laboratory work on body fluids, A Histological analysis of cell, tissue, and organ’s structure and function in normal and diseased conditions.

Trained in and practice different lab analyses, CEQ2000/8000, MDQ, PA 800, Gas Chromatography, and PCR, Knowledgeable in GMP; ISO 13485, CAPA

Knowledge of sterilization chemical analysis instrumentation.

COMPUTER SKILLS:

Microsoft Windows, Word, Excel, PowerPoint, Access, Microsoft Project, Visio, MS Project, Minitab

REFERENCE:

Excellent professional and personal references furnished upon request

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