Quality Assurance Management

Janet D. Shahbazi

Cell phone: 408-***-****

gcs669@r.postjobfree.com

Objective:

Self-motivated with over eight years of laboratory experience in biotech industry setting. Seeking new career challenges in the Pharmaceutical and Device industry. Detail oriented and organized, Skilled in planning and accomplishing goals, Perfect communication skills and Strong documentation expertise.

Education:

San Jose State University. San Jose, CA May 2012

M.S in Medical Product Development Management (MPDM)

Course Work Completed: Regulatory Affairs courses, Clinical Trials and Development courses; Project Management courses, Knowledge of medical products and a foundational overview of the development processes.

Familiar with 510K, ISO, Post Market Approval and Pre-Market Application (PMA), Investigational Device Exemption (IDE), and New Drug Application (NDA).

UCSC-Extension. Cupertino, CA December 2004

Certificate in Clinical Trial Design and Management program

Course Work Completed: Medical/Clinical Terminology, The Drug and Device Development process, Development of Clinical Sop’s (Standard Operating Procedures), Clinical Statistics for Non-Statisticians, Good Clinical Practice (GCP), Drug Safety and Adverse Events Reporting, Medical writing, Clinical Monitoring, FDA auditing and inspections.

San Jose State University. San Jose, CA May 1999

B.S. major in Microbiology, minor in Chemistry

Professional Experience:

CardioKinetix Inc. Menlo Park,CA (Medical Device, Class III) May 2011-Present

Quality Assurance Specialist Consultant

• Quality Systems Support

• Support IQA function by performing incoming inspections

• Support Document Control activities including DCO processing, document scanning and filing.

• Maintain and support the Approved Supplier List (ASL)

• Review standards on a bi-annual basis, at a minimum, to assure the most recent version is available in-house.

• Maintains and update a Standards Reference Index, along with the maintenance of current standards and archival of historical standards.

• Support Training function including data entry and filing.

• Provide quality support for all in-house manufacturing and R&D activities

• Support all regulatory filing activities as requested by management

• Review and process Document Change Orders (DCOs); maintain all CardioKinetix controlled documents, data and quality records (internal audit reports, nonconformance reports, CAPAs, etc.) per company procedures

• Perform Incoming Inspections of materials/subassemblies, ensure that all inspections are performed per established procedures and specifications

• Ensure proper labeling and inventory transfer of dispositioned materials and finished goods

• Process returned materials per company procedure

• Generate and revise quality system procedures

• Review lot history records and supporting documents for conformity

• Review and evaluate changes in worldwide regulatory requirements

• Prepare "Memo to File" reports to support internal filings for product development projects and product changes.

• Maintain quality records (such as regulatory agency and Notified Body correspondence) per established company procedures

• Collect quality system metrics per established procedure for management review reporting

• Issuing Travelers, Line Clearance Checklist, and associated documentation with specific lot numbers to Operations upon request.

• Maintenance and revision of the document control system.

• As a secondary reviewer, verifying and singing all completed DCO to ensure all action items have been completed.

• Perform thorough DMR and DHF review, including data entry

• Experience working in GMP /GLP environment.

• Maintaining and Controlling all necessary records and documentation according to corporate and departmental procedures and regulations.

• experience with Class III implantable medical devices.

Affymetrix, Santa Clara, CA. December2004-May 2008

Research Associate

Reagent Manufacturing- Assay Development, Documentations, manufacturing of Gene Chip(R) reagents

• Used, analyzed, and troubleshoot HPLC data and experienced in Affymetrix Gene Chip ® Microarrays

• Ran Agerose gels, PCR, RT-PCR, nucleic acid purification, amplification, and digestion, ligation, and hybridization technologies.

• Excellent communication skills including writing and speaking, the ability to work with multidisciplinary work teams, energetic and team player.

• Experienced in testing critical raw material and In-process testing of bulk material and reagents using established Standard operating procedures.

• Made buffers and reagents as necessary. Calibrated and maintained laboratory equipment according to standard operating procedures.

• Identified and troubleshoot equipment problems and paid attention to details.

• Performed validation protocols; executed experiments, and prepared validation reports.

• Reviewed all batch records, test methods, and specifications in preparation for final batch release.

• Obtained corrections to ensure compliance, as well as reviewed deviation reports, non-conforming material reports (Investigate, disposition and close Non-conformance Reports), and component envelopes for adherence to SOPs, as well as suggest process improvements.

• Performed GMP/GLP/ISO regulations for Reagent Manufacturing.

• Collected data for documentation of testing results and assured that predetermined specifications are met.

• Operated HP 8452 Diode-Array Spectrophotometer and ND-100 Nanodrop, and handle the Bioanalyzer 2100 chip against Agilent RNA 600 size standard.

• Interacted with Materials, Manufacturing, and Packaging regarding purchasing of laboratory supplies.

• Tested and released QC/QA reagents of products, compliance and documentation.

Deltagen, Inc., San Carlos, CA. October 1999 –July 2003

Research Associate II

Molecular Biology – Assay Development, Genotyping, & Management

• Applied broad-based molecular biology techniques to Deltagen’s high-throughput in vivo mammalian knockout pipeline.

• Ability to handle and track large data sets, consistently repeat experimental procedures and a strong background in PCR, nucleic acid amplification and hybridization technologies.

• Performed high-throughput PCR-based genotyping of knockout mice to determine if they carry the desired mutation using gene specific PCR and Taqman.

• Identified unknown genomic sequences using genome walker and various DNA extraction

• Used ABI 7700 real-time PCR system to do non-gene-specific genotyping.

• Executed Large-scale data management within a company-wide database as well as lab notebooks and maintenance of records.

• Carried out Fluorescent-based DNA sequencing on an ABI 377 including reactions, acrylamide gel operations, and analysis. Management tracking of all requests templates, and results for molecular biology department.

• Performed large scale plasmid purification, manipulation, and validation for use in creating homologous recombinants.

• Executed BLAST searches for gene specific PCR in primers design.

Idexx Veterinary lab Inc. San Jose January 1999 –October 1999

Research Assistance.

Applied Skills:

• Molecular biology: PCR, electrophoresis, plasmid DNA isolation, DNA transformation, DNA sequencing.

• Robotics: Analyzed genotyping samples using automated system (Caliper, Hamilton, ABI 7700, Fluorescent based DNA sequencing on an ABI 377).

• Computers: Proficiency with Excel, Microsoft Word, FileMaker Pro, Sequencher. Excellent organization in computer and verbal/written communication skills. Documentation: DCO processing, document scanning and filing, maintain and review domestic and international standards on a bi-annual basis, issuing Travelers; initiate, revise, or obsolete documents. Independent worker with ability to focus and detail oriented.

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