Nacéra Madani

240-***-****. ac9iqr@r.postjobfree.com

HIGHLIGHT OF QUALIFICATIONS:

Extensive experience in biotechnology and pharmaceutical Industry

Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)

Strong knowledge of GMP, SOPs and quality systems

Identifying, writing evaluating and closing Deviations and CAPA

Experience with internal audit principals

Knowledge of laboratory and production equipment IQ/OQ/PQ

Proficient in MS Word, Excel, Power Point and other applications

Strong written and verbal communication skills

Ability to communicate and work independently with scientific/technical personnel

Experience with the use of electronic quality systems such as Trackwise, LMS (Learning Management System), LIMS (Laboratory Information Management System), CLSD (Chemical Log solution Database), and DLIMS (Development Information Management System).

Proficiency in performing investigations, system suitability trend reports and utility trend reports.

Good understanding of cGMP, GLP and GXP

Understanding knowledge of Lean and 5 S claning.

Ability to work in a fast paced environment with multiple and competing priorities

Good Knowledge and training in different techniques such as ELISA, SDS-PAGE Cellulose Acetate Gel Electrophoresis, 2 D Gel Electrophoresis, and Western Blot.

Proficiency in the use of protein analyzers such as Nephelometer and BCS system

Strong experience in the use of various laboratory equipment; such as Endotoxin plate readers, UV spectrophotometer, Trinean Lab Chip TOC Analyzers, conductivity meters and pH meter.

Hands on experience and training in pharmaceutical testing equipment such as HPLC, Gas Chromatography, Dissolution testing and general pharmaceutical testing for solid dosage forms and liquid forms

Computer Skills: MS Word, MS Excel, MS Power Point, and outlook.

Ability to work independently and to effectively collaborate with others.

Excellent multitasking skills.

TRAINING AND EXPERIENCE:

Jan20015- Present Quality Control Analyst III

Medimmune/Astra Zeneca

Review laboratory test data.

Review data obtained for compliance to specifications and report abnormalities.

Perform Investigation Reports, deviation reports, system suitability and utility trend reports.

Write new standard operating procedures and revise existing documentation.

Initiate Change Control for new and existing equipment.

Participate in Lean Projects

Train junior analysts.

Perform routine and non-routine testing (bioburden, Endotoxin, pH, A280 protein concentration testing using UV spectrophotometer and Trinean LabChip, Nanofiltration assay, and Osmolality for in process and bulk manufacturing and finished product samples.

Perform Total Organic Carbon analysis, Bioburden for different type of water and cleaning verification samples.

Perform Gram Stain and Microbial Identification.

Perform Bioburden and endotoxin product qualifications

Maintain laboratory instrumentation according to maintenance schedules, SOPs and GMP requirements.

Complete appropriate documentation to support testing procedures including data capture forms, equipment logbooks, inventory forms and electronic data capture.

Write new standard operating procedures and revise existing documentation.

Initiate Validation System Change Report (VSCR) for new and existing equipment.

Perform Preventive Maintenance for Laboratory Equipment such as Milliflex Pump, Tecan Sunrise and Biotek plate Readers.

Train and provide assistance to junior analysts on various assays performed in the lab.

Participate in internal assessments and audits readiness.

Participate and provide inputs during daily meetings.

Jul20011- Jan2015 Quality Control Analyst II

Medimmune LLC, Gaithersburg, MD

Performed bioburden testing, Endotoxin, Nanofiltration, Osmolality and A280 of in-process, bulk manufacturing and finish product samples.

Performed Total Organic Carbon analysis using Shimadzu and Sievers 900 series, Bioburden, Endotoxin, Conductivity and water analysis testing for different type of water and cleaning verification samples.

Performed microbial colony enumeration on media plates and submitted excursion for microbial identification.

Performed investigation report, Utility Trend Reports and System Suitability Reports.

Investigated out of specifications results.

Performed equipment calibration and maintenance.

Revised existing procedures (SOPs).

Maintained POU Manuals.

Performed quarterly and annually System Suitability Reports and Utility Trend Reports.

Performed presentation related to Endotoxin and Bioburden testing.

Provided support and trained new hires.

Mar2009- Jul2011 Quality Control Analyst I

Medimmune LLC, Gaithersburg, MD

Performed bioburden testing, Endotoxin, Osmolality and A280 testing of in-process samples, bulk manufacturing and finished product samples.

Performed Total Organic Carbon analysis using Shimadzu Analyzers for different type of water and cleaning verification samples.

Performed Endotoxin, Conductivity and water analysis testing for different types of water.

Performed microbial colony enumeration on media plates and submitted excursion for microbial identification.

Archived and ordered logbooks.

Performed other duties as assigned.

Oct 2007- February 2008 Quality Assurance Documentation Specialist I

Medimmune LLC, Gaithersburg, MD

Electronically Issued lab notebooks, Log books, Master Production Records and Batch Records

assisted in identifying, researching and implementing process improvements that are supportive of departmental and corporate goals;

Reviewed and provide automatic document revision control to ensure that only the current version of a standard operating procedure SOP is available

Reviewed change controls of SOPs, MPRs/SPRs and other GMP documentation

Filed and retrieved documents within a standardized production system that allows for the efficient storage of and accessibility to large volume of records.

Communicated job completion to copy center manager.

Maintained strict adherence to policy and documented all job tasks and completion status.

EDUCATION:

Courses Achieved:

Cell Culture and Immunology

Montgomery College (Biotechnology Program)

Degrees:

Industrial pharmaceutical Technology Certificate, Seneca College, Toronto, Canada.

Bachelor of Pharmacy, University of Algiers, Algiers, Algeria.

Medical Laboratory Technologist Degree, University of Algiers, Algeria

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