Objective

Experienced & highly motivated candidate with over 9 years of quality experience working for medical device, pharmaceutical, and cosmetic organizations. Seeking opportunity to apply my skills to lead projects using Lean methods for continuous improvement following QSR and ISO 13485. I am a team player and a strong contributor in meeting critical timelines for high visibility projects.

Work Experience

Analyst II, Quality Assurance, CAPA Specialist/ Internal Auditor

Beckman Coulter, Chatsworth, CA [2015 – Present]

Successful remediation efforts to bring CAPA Management process into compliance and timeliness

Ensure compliance to FDA Quality System Regulations, 21 CFR 820, ISO 13485:2003/2012, JPAL and CMDCAS

Ensure sites CAPA procedures and processes are in compliance to global and applicable regulations and standards

Analysis of technical data submitted for CAPA review and final Submission of approval.

Reviewing supporting objective evidence for accuracy and completeness prior to final approval.

Train CAPA stakeholders on investigation for root cause using tools such as why’s, Fishbone, Fault tree analysis, DFMEA, FMEA etc.

Collect, analysis and provide metrics for monthly and quarterly management review

Maintain CAPA documentation audit ready for internal and external audits.

Internal Auditor complying with the following regulation:

oFDA 21 CFR 820, EN ISO 13485: 2012, ISO 13485:2003, EN ISO 14971:2012, CMDCAS, IVD Directive, MEDDEV, JPAL, GDP’s and GMP requirements

Quality Complaint Associate

Amgen Pharmaceutical Inc. Thousand Oaks, CA [2013 – 2015]

Initiate and coordinate product complaints.

Interface with call centers, various Amgen sites and business partners to ensure call intake process compliance.

Complete and approve product complaints requiring.

Reconcile reported product complaints to ensure entry in CMIS/IRPC

Perform return sample coordination and visual assessment.

Archive documents related to product complaints.

Provide support to the Global Product Safety Surveillance (GPSS) project, as needed Initiate and coordinate product complaints.

Safety representative: Evaluate field safety conditions through audit/monitoring, advice company management on findings.

Report and assist in the control of environmental hazards as mandated.

Quality Assurance Supervisor/ Documentation Supervisor

PureTek Corporation, San Fernando, CA [2010 – 2013]

Overseeing quality assurance in product manufacturing and batch auditing.

Leading employees through coaching, training and development for product manufacturing.

Direct and participate in the development and implementation of goals, objectives, policies and procedures for the Quality Assurance department.

Ensure from the Quality prospective the transfer of new products from R&D to production.

Managing internal and external auditing of quality systems.

Drive corrective actions/supplier corrective action requests (SCAR) within suppliers’ management process.

Audit company policies, procedures, and systems that affect product quality to assure compliance with the company’s quality system and good manufacturing processes.

Troubleshoot and resolve product quality problems by researching problems, analyzing data, and developments solutions to problems.

Hire, train, monitor and assist employees. Annual employee performance review.

Enforce company policies, establish performance standards and evaluate employee status.

Interface with third party auditors, Kosher Council, and county, state and federal

CAPA Specialist

PureTek Corporation, San Fernando, CA [2010 – 2013]

Coordinating investigation activities: product impact, root cause analysis, corrective & preventive action.

Monitoring of effectiveness checks and assuring all records meet defined criteria and are completed in a timely manner.

Trend analysis for all customer complaints report to corporate.

Support statistical techniques and management review.

Quality Assurance Lead

PureTek Corporation, San Fernando, CA [2009 – 2010]

Auditing the production batches for Physical, Chemical, and Microbiological results.

Assure that all the products are ready to ship with high quality and error free.

Education

California State University Northridge Northridge, CA

Major: Environmental & Occupational Health Science

Master of Science Degree [2009- 2012]

Educational training includes

Hazard material and waste management by following RCRA, CERCLA, and TSCA requirements.

Air pollutions and its effects on animals and plants.

Knowledge of occupational health, industrial hygiene calculation in regards to the regulation.

Using risk assessment to resolve environmental and occupational health issues.

Comprehensive analysis of environmental and occupational health program planning, with emphasis upon program management.

Analysis of research methodology and interpretation and conducting independent research.

University of California Los Angeles Los Angeles, CA

Major: Biology

Bachelor of Science Degree [2004 – 2007]

Pierce College Woodland Hills, CA

Associate Degree and Transfer Degree [2001- 2004]

Additional Job Experience

Documentation Specialist [2008 – 2009]

Preparing formulas, procedures, and Lab Specifications.

Preparing standard size batches.

Issuing documents and batches to production, Research & Development, and Quality Control.

Coordinating with Validation and Stability Departments and providing documents.

Laboratory Assistant

Quest Diagnostics, West Hills, CA [2007 - 2008]

Receiving the specimens, input them in computer

Culturing the specimens in different agar plates

Student Office Assistant

Pierce College, Job Placement Center

Woodland Hills, CA [2002 - 2004]

Filing, data entry, greeting customers, answering the phone, faxing, and copying, and helping others with computer usage.

Skills:

Kaizen

QSR & ISO 13485 Auditor

Risk management Specialist

CAPA Specialist

Change Order

Others kills:

Process Improvement, Analyzing Information, Verbal Communication, Informing Others, Quality Engineering, Emphasizing Excellence, Attention to Detail, Excellent organizational skills, Thoroughness, Dealing with Complexity. Identifying, assessing and controlling environmental factors that threatens the health and well-being of workers, the community and the environment. Multi language skills: Farsi, Dari, Urdu, Pashto, and English. Knowledge in advanced features in Microsoft Excel, Word, and PowerPoint.

Global CAPA

EDMS

Master Control

SharePoint

GDP and cGMP

Contact this candidate