Ghazaleh Azarani

**** ******* **.

Rockville, MD 20851

240-***-****

ac7j1y@r.postjobfree.com

Summary: Self-motivated and goal oriented business professional seeking a position to associate myself with an organization that provides me an opportunity to utilize my experience and knowledge and to be a part of the team that works dynamically towards the growth and development of a Pharmaceutical group. Background includes working in a range of fast-paced environments that provide opportunities to develop various skills including strong, collaborative communication, team work, customer service while upholding organizational policies and procedures.

Career

Experience:

Prometic BioTherapeutics

QA Specialist January 2016- Present

Responsible for the Quality Assurance assessment, review and approval of deviations, investigations, Out-off-Specification (OOS) and change control requests, in accordance with industry standards and requirements.

Manage Corrective Actions and Preventive Actions (CAPA) program.

Knowledgeable in LIMs and QMS.

Facilitate internal training on QA procedures. Assist and train technicians to accurately complete Laboratory Investigations Reports, Deviations, Corrective and Preventive Actions, and Change controls to resolve potential Equipment, Validation, and Analytical testing issues to improve quality and efficiency.

Oversee the creation and review of documents used in Development, Analytical Testing, Drug Product Release, and Stability practices for accuracy and completeness.

Perform record review to ensure compliance to relevant procedures.

Responsible for the final product release (BDS and DP).

Full batch record reviewing and approval in support of batch final release.

Participate in the drafting, review and approval of Standard Operating Procedures (SOPs)

Manages document control for filing and maintaining original documentation, as well as assigning/ tracking new document numbers

Perform audits of internal controls and risk assessments, as well as external audits on vendors.

Acquired Certification in GMP, GCP and GLP regulatory Guidelines through the European Center for Clinical Research Training (ECCRT)

Supports the facilitation of all aspects of GCP regulatory inspections.

Perform reviews on IOPQ documents and other validation projects to ensure they meet the requirements of regulatory agencies and industry current practices.

Initiate and/or review and approve Summary of Testing, and Certificates of Analysis to be released to external CMOs, CROs etc.

Assist in review, and approval of stability documentation for use in IND/ BLA submission.

Fisher Bioservices, Rockville, Maryland December 2011 – January 2016

QA/QC Associate- Perm,

Performing Technical pre and post review of the manufacturing batch records to be in compliance with cGMP regulatory requirements and internal procedures

Approving batch records for release of the products and managing implementation required for internal standards

Perform investigation, CAPAs, Deviations and QA hold based on review performed

Review and approval of investigation associated with Atypical results, discrepancy reports and out of tolerance documentation

Review stability data to ensure accuracy and conformance to specification

Create, revise and train on standard operating procedures

Became trained on Master Control for review and maintenance of change control for SOPs as well as other Client documentation

Actively participate in internal audits as well as customer audits

Update QA databases for batch record review status and compile record lot history

Assessment of nonconformance and root cause analysis for batch records, protocols and reports

Facilitate, compliance review and approval of change control as well as tracking, follow-up and reporting/ trending

Work directly with responsible departments in timely manner to lead change controls and laboratory investigations for closure in continuous improvement project

Inspection of in-process batch records on the floor to oversee the execution and sign in as the QA representative

Generate and analyze various quality metrics through maintaining change control documents electronically as well as managing documents

Following release testing protocol as well as performing stability procedures

Analyzing In Use stability data within analytical procedures as well as finished material in batch records

Perform raw material testing on variety of different samples including bodily fluids in addition to coagulation and required aliquoting

Creation and revision of Standard Operating Procedures

Review Specification and acceptance criteria for incoming Raw Material

Evaluation of Impurities in Drug product to avoid contamination

Work in Cryocart for shipments and receiving of patient specific drug samples

Determining the quality of raw material in order to reduce risk to product quality by testing shelf life, storage requirements, and determining status of materials

Learning Management System Administrator and certified trainer

Proficiently reviews and approves production work instructions for kit and batch execution.

QC inspection and release of products prior to shipment to client

Effectively communicates with QC team and all levels of management.

Ensures First Pass Provides training support

Participates in deviation and customer complaint management as well as CAPAs

Assists with Lean Board meetings and proves improvement.

Became the primary reinforcement for coverage for co workers through continuous error free and detail oriented work ethics with the increasingly high customer demands

Inventory Technician I- Temp, December 2011 – December 2012

Processing of aliquots specimens

Handled specimens of human, animal, and/or plant origin

Adhered to strict safety protocols

Worked closely with specimens at various temperature settings

Education: University of Maryland University College, College Park, Maryland

Masters in Biotechnology Management- Graduated in May 2017

GPA: 3.54

Laboratory Techniques/ Skills: Southern Blot, Gel Electrophoresis, Agrose gel, ELISA, Chromatography, Western Blot, SDS-PAGE

University of Maryland College Park, College Park, Maryland

Bachelor of Science, Specialized in General Biology – Graduated Spring of 2011

Laboratory experience:

Perform cell culture, cell treatment and cell sample preparation

oin vitro assessment

oUse of stain, dyes and various indicators to measure proliferation and viability

oConducting subculturing and cryopreservation

oGrowth of cell culture in various medium

Preparation of buffers and solutions for laboratory needs

Animal handing experience

Write reports, perform calculations, and enter data into computerized software

Conduct sample analysis using instruments such as pH meters, balances, centrifuges, auto-titrations and other instruments/procedures as required

Performing best practice sterile techniques and adhering to Good Manufacturing Practices (GMP) in the Lab

Montgomery College, Rockville Campus, Maryland

Associate of Arts – Fall of 2005 to Spring of 2008

Northwest High School, Germantown, Maryland

Diploma – Summer of 2005

Skills:

Microsoft Word, Excel, and PowerPoint

Fluent in English and Farsi

Demonstrated knowledge of regulatory agency inspections, internal and external audits.

Competency with computer applications such as MS Project, MS Office, SharePoint, and LIM’s.

High level of attention to details, accuracy and precision.

Ability to work independently as well as in a team.

Ability to Multitask.

Ability to adapt quickly to changing priorities and projects.

Excellent oral and written communication skills

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